Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam
Thoracentesis/ Paracentesis Kit 10/CS; STERILE;
The integrity of the sterile packaging is potentially compromised.
JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
Product Code: SN1015X / LOT 0000840334 ; Product Code: SN1016X / LOT 0000848028 ; Product Code: SN1017X / LOT 0000848018 ; Product Code SN7016X / LOT 0000848017
JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;
ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE;
JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;
Manometer, 550 ml three-Way Stopcock; STERILE;
Product distributed to the following US states and countries: AK, AL, AR, Austria, AZ, CA, Canada, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, United Kingdom, UT, VA, WA, WI, and WV
Kratom powder labeled in the following ways 1) Enhance Your Life, Kratom Essence Maeng Da Mitragyna speciosa, 150 gras;  2) Bali Kratom, 15 g Powdered; 3) Bali Kratom, 30 g Powdered; 4) Bali Kratom, 60 g Powdered; 5) Bali Kratom, 120 g Powdered; 6) Botany Bay, 1 oz
The firm's dietary supplement products contain kratom (Mitragyna speciosa), a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury;
All lot codes with expiration dates after 1/31/2018
Kratom capsules labeled in the following ways: 1) Divinity Kratom 10 Capsule Dietary Supplement, Divinity Product LLC, Blue Springs, MO 64015; 2) Divinity Bali Kratom, 10PK Capsules; 3) Divinity Bali Kratom, 20PK Capsules; 4) Divinity Bali Kratom, 40PK Capsules;
Fornier Phantom Fiber(TM) Sutures:  Item Number	Description  SMB000425	4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES  SMB000525	5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES  SMP000425	4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES  SMP000525	5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES  SMSB0110	1PK PHANTOM FIBER SZ 2 WHITE  SMSB0110N   	lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED  SMSB0112	10 PK PHANTOM FIBER SZ 2 WHITE  SMSB0112N  	10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED  SMSB0120	1PK PHANTOM FIBER SZ 2 VIOLET  SMSB0120N	lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED  SMSB0122	10 PK PHANTOM FIBER SZ 2 VIOLET  SMSB0122N	10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED  SMSB0130	1PK PHANTOM FIBER SZ 2 WHITE/VIOLET  SMSB0132	10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET    Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored.  This may impact the shelf-life of the product which could cause the suture to lose strength more quickly than expected.
Worldwide Distribution -- USA and Europe.
Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002.     Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a recipient.
Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag..
Philips Electronics North  America Corporation
Intera 0.5T Standard, Model 781101    Product Usage:  Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Potential risk for helium gas inside the MR examination room during a magnet quench
Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multiva 1.5T Model 781076, & 5) Multiva 1.5T 16ch R5 based Model 781078     Product Usage:  Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8)  Achieva 1.5T Model 781382     Product Usage:  Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
T5 Model 78104     Product Usage:  Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103     Product Usage:  Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
ACS-NT, Model 78108    Product Usage:  Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4) Magnet HFO, Model 781495, 5) Magnet Multiva 16, Model 781496, 6) Magnet Multiva 8, Model 781497 & 7) Magnets Ingenia 1.5T CX, Model 781498       Product Usage:  Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Conversion SmarthPath to dStream for 1.5T, Model 781260    Product Usage:  Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
T5-NT, Model 78104    Product Usage:  Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4)   Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T Pulsar Model 781170, 8) Intera 1.5T Achieva Pulsar Model 781171, 9) Intera 1.5T Achieva Nova Model 781172, 10) Intera 1.5T Achieva CV Nova Model 781174,   11) Intera 1.5T Achieva IT Nova Model 781174, 12) Intera 1.5T Achieva I/T Nova Dual Model 781176, 13) Intera 1.5T Model 781195 & 14) Intera 1.5T Pulsar New Model 781295
T10-NT, Model 78107    Product Usage:  Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Panorama 1.0T, Model 781250    Product Usage:  Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Ingenia 1.5T CX, Models 781261 & 781262    Product Usage:  Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
AK, GA, IA, IN, KY, MN, MO, ND, NH, NY, OH, TX, WI
Midwest Northern Nut Redskin Peanuts.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90112.  2.    2.  Net Wt. 5 lbs.  3.  Net Wt. 30 lbs.  Midwest Northern Inc., Minneapolis, MN  55118
potential Allergen cross contact in oil used to roast various nuts and seeds products.
Midwest Northern Nut Blanched Peanuts packaged in the following sizes:    1.  Jumbo Peanuts.  Net Wt. 16 oz. (454G), UPC 38043-90013.    2.  Blanched Jumbo Peanuts Roasted & Salted,  Net Wt.  5 lbs.  2.  Granulated Blanched Peanuts Roasted & Salted, Net Wt 30 lbs.    3.  Blanched Jumbo Peanuts Roasted & Salted, Net Wt 30 lbs.     4.  Dry Roasted & Salted Peanuts, Net Wt. 5 lbs.    5.  Dry Roasted & Salted Peanuts, Net Wt. 25 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut  Texas Twist, Snack Mix.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90083.    2.  Net Wt. 5 lbs.  3.  Net Wt. 25 lbs.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut  Nutty Fruit Mix, Trail Mix.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90027.    2,  Net Wt. 25 lbs.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Cashews packaged in the following sizes:    1.  Jumbo Cashews.  Net Wt. 16 oz. (454G), UPC 38043-90008.  Net Wt. 5 lbs.  2.  Large Whole Cashews Roasted & Salted.  Net Wt. 10 lbs.    3.  Cashew Splits & Butts, Net Wt. 16 oz. (454G), UPC 38043-90009, Net Wt. 5 lbs.    4.  Cashews Large Splits Roasted & Salted, Net Wt. 5 lbs.    5.  Cashews Large Pieces Roasted & Salted  Net Wt. 5 lbs.   Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Cajun Cracker Mix, Snack Mix.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90032.    2.  Net Wt.  5 lbs.    3.  Net Wt. 20 lbs.    4.  Net Wt. 25 lbs.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut BBQ Blues Mix.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90084.    2.  Net Wt. 5 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Buffalo Style Peanuts.  Net Wt. 16 oz. (454G), UPC 38043-90086.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Cranberry Nut Trail Mix,  Net Wt. 25 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Franz Mix, Nut Mix,  Net Wt. 30 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Sea Salt & Pepper Peanuts.  Net Wt. 16 oz. (454G), UPC 38043-90127.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Lake Elmo Mix.  Net Wt. 25 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Pecan Pieces, Roasted NO Salt.   Net Wt. 5 lbs.      Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut GORP Mix, Trail Mix.  Net Wt. 5 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Roasted Salted Natural Almonds. Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90002.    2.  Net Wt. 5 lbs.    3.  Net Wt 10 lbs.    4.  Net Wt.  30 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Cheddar Treat Snack Mix,   Net wt. 5 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Mendakota Mix.  Net Wt. 25 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Party Mix, Roasted & Salted Nut Mix.   Net Wt. 30 lbs.      Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Roasted NO Salt Peanuts packaged in the following sizes:    1.  Granulated Blanched Peanuts Roasted No Salt.   Net Wt. 5 lbs.      2.  Dry Roasted No Salt Peanuts, Net Wt. 5 lbs.  3.  Blanched Jumbo Peanuts, Roasted NO Salt, Net Wt. 30 lbs.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Happy Snack Mix.  Net Wt. 25 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Roasted Trail Mix.   Net Wt. 25 lbs.      Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Happy Hour Mix, Snack Mix.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90029.    2.  Net Wt. 25 lbs.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Walnut Pieces Packaged in the following sizes:    1.  Roasted & Salted Walnuts Hlvs & Pcs.  Net Wt.25 lbs.   2.  Walnuts Medium Pieces, Roasted & Salted, Net Wt. 30 lbs.     Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Cashew Large Pieces Roasted NO Salt.  Net Wt. 5 lbs.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Dawn's Chopped Mix, Roasted & Salted,  Net Wt. 30 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Pumpkin Seeds Roasted Salted.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90080.    2.  Net Wt. 5 lbs.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut  Hokey Pokey, Gourmet Carmel Corn.  Net Wt. 12 oz. (340G), UPC 38043-40039.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Bakers Chopped Mix, Roasted & Salted  Packaged in the following sizes:    1.  Net wt. 5 lbs.    2.  Net Wt. 10 lbs.    3.  Net Wt. 30 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Caterer's Mix, Roasted & Salted Nut Mix.  Net wt. 5 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Pure Nut Topping.   Net Wt. 30 lbs.      Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut  Sweet & Salty, Snack Mix.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90035.    2.  Net Wt. 5 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Von Hanson's Spicy Trail Mix, Snack Mix.  Net Wt.25 lbs.      Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Swiss Delight, Trail Mix.   Net Wt. 5 lbs.      Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Fulton Mix,  Net Wt. 25 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Food Service Trail Mix.  Packaged in the following sizes:    1.     Net Wt. 5 lbs.  2.  Net Wt. 8 / 5 lbs.      Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Oriental Mix, Snack Mix.  Packaged in the following sizes:    1.  Net Wt. 5 lbs.  2.  Net Wt. 10 lbs.    3.  Net Wt. 15 lbs.      Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut  Smokey Mountain Mix, Snack Mix.  Net Wt. 12 oz. (340G), UPC 38043-90133.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Mardi Gras Mix, Snack Mix.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90064.    2.  Net Wt. 25 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Spanish Peanuts.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90011.    2.  Net Wt. 30 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut  Sizzlin' Sweet, Snack Mix.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90079.    2.  Net Wt. 10 lbs.  3.  Net Wet 25 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Cinnamon Apple Mix, Trail Mix.  Net wt. 5 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Garlic Crunch, Snack Mix. Packaged in the following sizes:    1.  Net Wt. 12 oz. (340G), UPC 38043-90034.    2.  Net Wt. 5 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Sunflower Seeds Fine Grind, Roasted Salted.   Net Wt. 25 lbs.      Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut  Midwest Trail Mix, Trail Mix.  Net Wt. 16 oz. (454G), UPC 38043-90031.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Lifetime Trail Mix.  Net Wt. 25 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut  Backwoods Trail Mix.  Net Wt. 5 lbs.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Sweet Treat, Trail Mix.   Net Wt. 5 lbs.      Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut  Natural Snacks, Trail Mix.  Net Wt. 16 oz. (454G), UPC 38043-90028.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Criss Cross Mix, Trail Mix.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90026.    2.  Net Wt. 5 lbs.  3.  Net Wt. 25 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut  Sesame Treat, Snack Mix.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90030.    2.  Net Wt. 25 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Pumpkin Seeds, Roasted NO Salt.   Net Wt. 5 lbs.      Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Hot Cha Cha Mix, Snack Mix.  Net Wt. 12 oz. (340G), UPC 38043-90134.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Macadamia Nuts.  Net Wt. 8 oz. (227G), UPC 38043-90021.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Chopped Mix I Roasted NO Salt,   Net Wt. 30 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut  Pee Bee Gee Bee, Gourmet Carmel Corn.  Net Wt. 12 oz. (340G), UPC 38043-90065.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Asian Snack Mix. Packaged in the following sizes:   1.   Net Wt. 16 oz. (454G), UPC 38043-90092.    2.  Net Wt. 25 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Fancy Deluxe Mix, Nut Mix.  packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90000.    2.  Net Wt. 5 lbs.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Cajun Peanuts.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90015.    2.  Net Wt. 25 lbs.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Sunflower Seeds Roasted No Salt.  Net Wt. 16 oz. (454G), UPC 38043-90146.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Student Mix, Trail Mix.   Net Wt. 10 lbs.      Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Hulled Pistachios, Roasted Salted.   Net Wt. 10 lbs.      Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Pecans Roasted & Salted.  Packaged in the following sizes:    1.  Net Wt. 16 oz. (454G), UPC 38043-90145.    2.  Pecan Mammoth Halves, Roasted & Salted.  Net Wt. 30 lbs.    3.  Pecan Pieces Roasted & Salted Net Wt. 30 lbs.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Sunflower Seeds Hulled Roasted & Salted. Packaged in the following sizes:    1.   Net Wt. 16 oz. (454G), UPC 38043-90024.    2.  Net Wt. 5 lbs.  3.  Net Wt. 30 lbs.  Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Tropical Mix, No Carob - No Coconut, Trail Mix.  Packaged in the following sizes:    1.  Net WT. 5 lbs.  2.  Net Wt.25 lbs.      Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Fruit & Nut Mix, Trail Mix,  Net Wt. 10 lbs.    Midwest Northern Inc., Minneapolis, MN  55118
Midwest Northern Nut Heart Healthy Mix, Nut Mix.  Net Wt. 12 oz. (340G), UPC 38043-90118.  Midwest Northern Inc., Minneapolis, MN  55118
Product was shipped to the following states: IL, ME, MI, NC & OH.
Provim ESP Vita Wheat Gluten, Product code 6303, 50 lb bag
The firm was notified by their supplier that the flour used to manufacture the product tested positive for Listeria monocytogenes.
Worldwide distribution.  US nationwide including Puerto Rico, ARGENTINA, AUSTRALIA, BAHAMAS, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., ECUADOR, EL SALVADOR, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LEBANON, MALAYSIA, MEXICO, NEW ZEALAND, PERU, PHILIPPINES, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.
32,189 cases (20 units per case - 643,780 units) total
Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.
Product Description, Product code:      a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN), 227;    b. HALYARD* TRACH CARE-72 DSE ENDO 14FR, 227-5;    c. HALYARD* TRACH CARE-72 WET PAK* 14FR, 22701356-5;    d. HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR, 2270156-5;    e. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN), 22703;    f. HALYARD* TRACH CARE-72 DSE TRACH 14FR, 22703-5;    g. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR, 227036-5;    h. HALYARD* TRACH CARE-72 DSE ENDO 10FR, 227101-5;    i. HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK), 2271013;    j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR, 2271018-5;    k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR, 2271218-5;    l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 22712183;    m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR, 22712186-5;    n. HALYARD* 72 DSE TRACH CARE 12FR, 227121863-5;    o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN), 2271418;    p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR, 2271418-5;    q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN), 22714183;    r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR, s. 22714183-5;    s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR, 22714186;    t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR, 22714186-5;    u. HALYARD* TC-72 WET PAK DSE 14FR, 227141863-5;    v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN), 227147;    w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE), 22716;    x. HALYARD* TRACH CARE-72 DSE ENDO 12FR, 22716-5;    y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 2271603;    z. HALYARD* TRACH CARE-72 DSE TRACH 12FR, 2271603-5;    aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR, 22716036-5;    ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE), 227161;    ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM, 227161-5;    ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR, 2271613-5;    ae.  HALYARD* TRACH CARE-72 DSE ENDO 16FR, 2271616-5;    af. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 16FR, ag. 2271618
Product Description, Product code:      a. HALYARD* MULTI-PORT, DSY, ENDO 10FR, 24010-5;    b. HALYARD* MULTI-PORT, DSY, ENDO 12FR, 240121-5;    c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR, 240128-5;    d. HALYARD* MULTI-PORT, DSY, ENDO 14FR, 24014-5;    e. HALYARD* MULTI-PORT, DSY, TRACH 14FR, 240143-5;    f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR, 2401436-5;    g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR, 2401438-5;    h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR, 240146-5;    i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR, 240146-5N;    j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR, 240148-5;    k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR, 240168-5;      j. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR, 2271018-5;    k. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR, 2271218-5;    l. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 22712183;    m. HALYARD* 72 DSE MDI BUILT IN ENDO 12FR, 22712186-5;    n. HALYARD* 72 DSE TRACH CARE 12FR, 227121863-5;    o. HALYARD* 14FR DSE 22.2IN/56CM (GREEN), 2271418;    p. HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR, 2271418-5;    q. HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN), 22714183;    r. HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR, s. 22714183-5;    s. HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR, 22714186;    t. HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR, 22714186-5;    u. HALYARD* TC-72 WET PAK DSE 14FR, 227141863-5;    v. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54CM (GREEN), 227147;    w. HALYARD* TURBO-CLEANING 12FR DSE 21.3IN/54 CM (WHITE), 22716;    x. HALYARD* TRACH CARE-72 DSE ENDO 12FR, 22716-5;    y. HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 2271603;    z. HALYARD* TRACH CARE-72 DSE TRACH 12FR, 2271603-5;    aa. HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 12FR, 22716036-5;    ab. HALYARD* TURBO-CLEANING 16FR DSE 21.3IN/54CM (ORANGE), 227161;    ac. HALYARD* TRACH CARE-72 DSE 16FR 21.3IN/54CM, 227161-5;    ad. HALYARD* TRACH CARE-72 DSE TRACH 16FR, 2271613-5;    ae.  HALYARD* TRACH CARE-72 DSE ENDO 16FR, 2271616-5;    af. HA
Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following:      a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE);    b. HALYARD* 12 FR TRACH CARE DSE ENDO;    c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE);    d. HALYARD* 12FR TRACH CARE DSE TRACH;    e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN);    f. HALYARD* 14FR TRACH CARE DSE ENDO;    g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN);    h. HALYARD* 14FR TRACH CARE DSE TRACH;    i. HALYARD* 14FR DSE 12IN/30.5CM;    j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH;    k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO;    l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO;    m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO;    n. HALYARD* 14FR TRACH CARE DSE MDI ENDO;    o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN);    p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO;    q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE);    r. HALYARD* 16FR TRACH CARE DSE ENDO;    s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO
Product Description, (Product code):        a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE), (2160);    b. HALYARD* 12 FR TRACH CARE DSE ENDO, (2160-5);    c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE), (21603);    d. HALYARD* 12FR TRACH CARE DSE TRACH, (21603-5);    e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN), (22108130, 2210, 22106, 22107, 22108, 22108147, 8224);    f. HALYARD* 14FR TRACH CARE DSE ENDO, (2210-5);    g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN), (22103, 221037, 221038, 8223, 221036);    h. HALYARD* 14FR TRACH CARE DSE TRACH, (22103-5);    i. HALYARD* 14FR DSE 12IN/30.5CM, (221036-5);    j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH, (2210386-5);    k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO, (22106-5);    l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO, (221069-5);    m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO, (22107-5);    n. HALYARD* 14FR TRACH CARE DSE MDI ENDO, (22108-5);    o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN), (22108148, 22109);    p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO, (22109-5);    q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE), (2260, 22606);    r. HALYARD* 16FR TRACH CARE DSE ENDO, (2260-5);    s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO, (22606-5)
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
Lot Number: 0006661251, Expiration date: 02/28/2018
Davis Chocolate a division of Deco Chem, Inc.
Davis Chocolate Peanut Morsels /Organic Peanut Chips
2840 lbs of lot GMPBMO-25 and 1960 lbs of lot GMPBMO-26
Davis Chocolate Inc., voluntarily removed organic peanut butter chips from a wholesale account due to a customer's laboratory analysis of the product indicating the presence of Listeria monocytogenes.
Production Information: Davis Chocolate Peanut Morsels lot GMPBMO-25/FTORK-DCPC-13 was produced starting February 8, 2018 and finishing on February 14, 2018. Lot GMPBMO-26/FTORK-DCPC-14 had production dates of February 15-23, 2018.
Angiodynamics Inc. (Navilyst Medical Inc.)
Recall conducted to end user level.  Recall Notifications were delivered by Fed Express.
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management  and/or Invasive Pressure Monitoring systems.
NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure.
River Valley Garlic/Alfalfa Sprouts in 5 ounce Cup, UPC 87906-00016, 4 ounce clam shell, UPC  87906-00026
Alfalfa Sprouts have the potential to be contaminated with Salmonella.
River Valley Alfalfa Sprouts in 4 ounce Clam shell, UPC 87906-00027, 5 ounce plastic cup, UPC  87906-00006, and 2 lb. bag
River Valley Variety Sprouts in 5 ounce Cup, UPC 87906-00018
Product was shipped to the following states:AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, ME, MI, MN, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA & WI.
SANTA CRUZ organic CONCORD GRAPE fruit spread NET WT 9.5 OZ (270 g)     UPC 0 36192 10517 9
The firm was notified that the product did not have an ingredient panel or firm information on the label.
SANTA CRUZ organic SEEDLESS RED RASPBERRY fruit spread NET WT 9.5 OZ (270 g)     UPC 0 36192 10513 1
SANTA CRUZ organic MANGO fruit spread NET WT 9.5 OZ (270 g)     UPC 0 36192 10516 2
SANTA CRUZ organic STRAWBERRY fruit spread NET WT 9.5 OZ (270 g)     UPC 0 36192 10515 5
SANTA CRUZ organic APRICOT fruit spread NET WT 9.5 OZ (270 g)     UPC 0 36192 10514 8
SANTA CRUZ organic BLACKBERRY POMEGRANATE fruit spread NET WT 9.5 OZ (270 g)     UPC 0 36192 10510 0
Product was distributed throughout the United States.
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India  382213, NDC 36000-002-10
Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
US and Argentina, Belgium, Brazil, Chile, Colombia, Germany, Italy, Mexico, Peru, Thailand, and United Kingdom
WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R
MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA
Human Fetal Hemoglobin (HBF-1) FITC Conjugate
Three lots of Human Fetal Hemoglobin FITC Conjugate are displaying high background and unusual bright staining in the controls and patient samples which could potentially lead to erroneous results (i.e. false positives)
Lupin Cefdinir powder  for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202
This device was mislabeled and is not the correct component for this patient.
Worldwide Distribution -- US, to the state of California; and, the countries of Canada and Germany
Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K.    Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
Lot numbers:   33434, expiration date: 2022-04;  33945, expiration date: 2022-05;  34294, expiration date: 2022-06; and   34987, expiration date: 2022-07.
Dr. Pepper Est. 1885 Diet, 20 FL Oz (1.25 PT), 591 mL
Swire Coca Cola is recalling certain Diet Dr Pepper bottle due to the potential presence of foreign material.
B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Testosterone 37.5 mg pellet packaged in amber vial,   Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave.   #101, Las Vegas, NV 89119 (702) 791-3800
Lipoic Acid 25mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Estradiol 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Estradiol 10 mg  (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Estradiol 20 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Testosterone/Anastrozole 200 mg/20 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Testosterone 100 mg pellet packaged in amber vial,   Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave.   #101, Las Vegas, NV 89119 (702) 791-3800
Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL amber vial and b) 50mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
TM #4 (ALP 20/PAPAV/PHENT 2), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Estradiol 25 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Testosterone 200 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3
Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Testosterone/Estradiol 60 mg/6 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800    Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, twist top surrounded by a wrapper    Testosterone/Finasteride 80mg/8mg pellet Amber vial, twist top surrounded by a wrapper     Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, twist top surrounded by a wrapper
Pregnenolone 100 mg (SD) pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Testosterone 80 mg pellet packaged in amber vial,   Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave.   #101, Las Vegas, NV 89119 (702) 791-3800
Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
TM #3 (ALP10/PAPAV12/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Testosterone Propionate 100mg/mL, 5 mL amber vial,   Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Nandrolone decanoate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Testosterone Cypionate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
MVI-7 (B1-100mg/B3-100mg, B5-252 mg, B6-102mg, Vit C-2500 mg, B12-10mg, Mag-1000 mg)/ vial liquid injectable, 50 mL amber vial, Rx only,  Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Naltrexone 200 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
HCG 1000 units/mL, packaged in a) 2 mL and b) 6 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Biotin Suspension 10mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Progesterone 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800   twist top surrounded by a wrapper,
Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in a) 5 mL amber vial, and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
TM #6 (ALP 25/PAPAV/PHENT1), 3 mL amber vial,   Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
TM (ALP 50/PAPAV 30/PHENT1.5 mg), 3 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Testosterone 25 mg pellet packaged in amber vial,   Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave.   #101, Las Vegas, NV 89119 (702) 791-3800
Estradiol 55 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Testosterone 50 mg pellet packaged in amber vial,   Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave.   #101, Las Vegas, NV 89119 (702) 791-3800
Testosterone/Finasteride 80 mg/8 mg pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Testosterone/Anastrozole 60 mg/1 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Testosterone/Anastrozole 60 mg/4 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Estradiol 40 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Estradiol 12.5 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Estradiol 15 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Testosterone/Anastrozole 120 mg/8 mg pellets packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
CoEnzymeQ10 25mg/mL, 5mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vial,   Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Testosterone 55 mg pellet packaged in amber vial,   Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave.   #101, Las Vegas, NV 89119 (702) 791-3800
Vitamin D 50,000 unit/ml, 5 mL amber vial, Injectable Liquid, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. # 101, Las Vegas, NV 89119 (702) 791-3800
Testosterone 40 mg pellet packaged in amber vial,   Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave.   #101, Las Vegas, NV 89119 (702) 791-3800
Estradiol 35 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Product: Milford Smartbase   Model #  9934105 Pride SmartBase  Pride product codes: LSMPLCG A & LSMPLCG B
Recalling firm was informed that as a result of combination of a weak spring and incorrect alignment of the locking pin for latching the leg positions, product legs folded inwards while lifting a person off a bed and the individual was dropped.
US Distribution . Only one consignee was shipped 16 units of the affected device.
Solid state x-ray imager (flat panel/digital imager)      Solid state x-ray imager (flat panel/digital imager)  Medical
While transporting the portable machine with the retrofit equipment in a backwards motion, there is potential for foot injury from the underside of the detector bin of the retrofit unit.
Model Number GMR40.  Serial numbers 00001 through 00016.
Kitchen's Cravings Egg Salad Sandwich on Oat Multigrain Bread.  Net Wt. 5.5 oz. (156g),  Black bottom clear top plastic clamshell container, UPC 39779-00079   Keep Refrigerated.
Kwik Trip is recalling Kitchen's Cravings Premium Egg Salad Sandwich on Oat Multigrain Bread because it may contain undeclared fish and shellfish.
IA, IL, KS, MI, MN, MO, MT, ND, NE, SD, UT, WI
Mrs. Gerry's Egg Salad, Net Wt. 5 lb. (2.26kg), UPC 17839-60605.  Keep Refrigerated.  Manufactured by Mrs. Gerry's, Albert Lea, MN  56007
Firm is recalling various Egg Salads and Potato Salads because they may contain undeclared traces of imitation crab meat
Potato Salad packaged in the following branded and sized containers:    1.  Mrs. Gerry's Old Fashioned Potato Salad, Net Wt. 1 lb. (454 g) UPC 17839-94101,    Net Wt. 3 lb. (1.36 kg), UPC 17839-94103.  Net Wt. 5 lb. (2.27 kg), UPC 17839-94105.  Keep Refrigerated.  Manufactured by Mrs. Gerry's, Albert Lea, MN  56007.    2.  Open Acres Chunky Potato Salad with Egg, Net Wt. 16 oz. (1 lb.) 454 g, UPC 84853-62039.  Distributed by Pique Brands, Inc., Grand Rapids, MI.
Mrs. Gerry's Deviled Egg Potato Salad, Packaged into the following size containers:    1.  Net Wt. 3 lb. (1.36 kg) UPC 17839-09003,     2.  Net Wt. 5 lb. (2.26 kg), UPC 17839-09005.    3.  Net Wt. 12 lb. (5.45 kg), UPC 17839-09012  Keep Refrigerated.  Manufactured by Mrs. Gerry's, Albert Lea, MN  56007
Festival Foods Potato Salad packaged in the following size containers:     Net Wt. 6 oz. (170g), UPC 17839-22388, Net Wt. 1 lb. (454 g) UPC 17839-22301,    Net Wt. 3 lb. (1.36 kg), UPC 17839-22303.  Net Wt. 35 lb. 15.87 kg), UPC 17839-22335.  Keep Refrigerated.  Made for Festival Foods, Onalaska, WI  54650
Mrs. Gerry's Knowlan's Homestyle Potato Salad Net Wt. 12 lbs. (5.44 kg), UPC 17839-22912.  Keep Refrigerated.  Manufactured by Mrs. Gerry's, Albert Lea, MN  56007
Potato Salad packaged in the following branded and sized containers:    1.  Mrs. Gerry's Deli Fresh Potato Salad, Net Wt. 1 lb. (454 g) UPC 17839-93001,    Net Wt. 3 lb. (1.36 kg), UPC 17839-93003.  Net Wt. 5 lb. (2.26 kg), UPC 17839-93005.  Net Wt. 12 lb. (5.44 kg), UPC 17839-93012  Keep Refrigerated.  Manufactured by Mrs. Gerry's, Albert Lea, MN  56007.    2.  Open Acres American Potato Salad, Net Wt. 3 lb. (1.36 kg), UPC 84853-62044.  Distributed by Pique Brands, Inc., Grand Rapids, MI.
Mrs. Gerry's Original Potato Salad, Packaged into the following size containers:    1.  Net Wt. 1 lb. (454 g) UPC 17839-10201,     2.  Net Wt. 13 lb. (5.89 kg), UPC 17839-10213.    3.  Net Wt. 35 lb. (15.87 kg), UPC 17839-10235  Keep Refrigerated.  Manufactured by Mrs. Gerry's, Albert Lea, MN  56007
Mrs. Gerry's Homestyle Egg Salad, Net Wt. 5 lb. (2.27kg), UPC 17839-60905.  Keep Refrigerated.  Manufactured by Mrs. Gerry's, Albert Lea, MN  56007
Mrs. Gerry's Kwik Trip Egg Salad, Net Wt. 35 lb. (15.87kg), UPC 17839-61135.  Keep Refrigerated.  Manufactured by Mrs. Gerry's, Albert Lea, MN  56007
Mrs. Gerry's Market Fresh Potato Salad Net Wt. 12 lbs. (5.44 kg), UPC 17839-94212.  Keep Refrigerated.  Manufactured by Mrs. Gerry's, Albert Lea, MN  56007
Mrs. Gerry's Gourmet Potato Salad, Net Wt. 12 lb. (5.44 kg), UPC 17839-10112.  Keep Refrigerated.  Manufactured by Mrs. Gerry's, Albert Lea, MN  56007.
Worldwide Distribution - USA (nationwide) and the following countries: AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA,  CZECH REPUBLIC, GERMANY, DENMARK, NETHERLANDS, NORWAY, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, ITALY, JAPAN, KOREA, KUWAIT,  MALAYSIA, NORWAY, NEW ZELAND, SAUDI ARABIA, SWEDEN, SINGAPORE, SLOVENIA,  THAILAND
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector   07340153700246, 07340153700253, 07340153700260, 07340153700277     Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.
There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109,  07340153700116      Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.
Intra-Aortic Balloon Catheter Mega 7.5FR 30cc    Product Usage:  The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Catheter was missing the Contraindications section.
Intra-Aortic Balloon Catheter Mega 8FR 500cc  Product Usage:  The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc    Product Usage:  The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Worldwide Distribution - USA (nationwide)  and the following countries:Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Botswana, Brazil,  Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Liechtenstein, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Monaco, Mozambique, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, Turkmenistan, United Kingdom, Utd.Arab.Emir. and Vietnam.
Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751    Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professsionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.
The invasive pressure visual and audible alarms may not activate.
Worldwide Distribution: US (Nationwide), Australia, Belgium, Canada, Chile, China. Colombia, Dominican Republic, England, Finland, France, Germany, Greece, HK, India, Indonesia, Iran. Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates,and Vietnam.
Terumo HX2 Temperature Management System, Catalog No. 809810    The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
Update to cooler-heater cleaning instructions.
Sarns   TCM, Catalog No. 15747    The Sarns TCM is indicated for controlling and monitoring patient temperature .
Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014    The Sarns TCM is indicated for controlling and monitoring patient temperature .
SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system  Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
US Nationwide in the states of  AU, CA, NZ
Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50    Product Usage:  for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.
Nirvanio Green Malay Kratom 25 count bottle
Dietary supplements have the potential to be contaminated with Salmonella.
Nirvanio Special Reserve Kratom 50 count bottle
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15
Worldwide Distribution - USA (nationwide) to the states of : AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of :  Australia, South Korea, Malaysia, Netherlands, and Singapore.
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38    The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
1,145 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf
There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 gram tube, UPC #851357003004, NDC #75940-111-60
Microbial Contamination of Non-Sterile Products
Worldwide Distribution - US Nationwide in the states of: OH and OR, and Foreign distribution to Australia, China, Cuba, France, and South Africa.
Ingenuity TF PET/CT, Model No. 882442    Product Usage:  The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for diagnostic study and therapeutic planning. The system also provides tools for the quantification of results of the CT and PET images and provides the means for a simplified review of the CT, PET, and fused images. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease.
Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.
GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Malta, Mexico, Morocco,  Norway, Poland, Portugal , Romania, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab, United Kingdom and Venezuela.
GE Healthcare Lunar:   a) DPX Duo, Model Number: LU41693  b) DPX Bravo, Model Number:  LU41692    Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.
Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS.
a) DPX Duo, Model Number: LU41693  b) DPX Bravo, Model Number:  LU41692
GE Healthcare:  a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626,  LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365   b) Prodigy Advanced, Model Numbers:  LU42361, LU42397    Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.
GE Healthcare Lunar:   a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369  b) DPX MD+, Model Numbers:  LU8230, LU40338, LU40352    Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.
a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369  b) DPX MD+, Model Numbers:  LU8230, LU40338, LU40352
Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)
MINC Benchtop Incubator (Mini Incubator)  catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.
MINC Benchtop Incubator (Mini Incubator)  catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
Worldwide Distribution -- USA, Argentina, Bolivia, Brazil, Canada, Colombia, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.
Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275.    Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.
Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.
Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607.    Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.
Club 13 Kratom Maeng Da Red capsules;  5, 25, 50, 100, 120 capsule bottles, and Club 13 Kratom Maeng Da Red capsules in bulk bags.
7,683 units and 128 kg of capsules in bulk bags
Samples of Maeng Da red powder were tested and resulted positive for Salmonella.
Club 13 Kratom Maeng Da Red XS capsules;  5, 20, 25, 40, 50 capsule bottles
Club 13 Kratom Maeng Da Red powder;  Pouches of 15, 30, 90, 150, 454 grams, and Club 13 Kratom Maeng Da Red powder in bulk bags.
Aurora Area Blood Bank Dba Heartland Blood Centers
Apheresis Red Blood Cells, Leukocytes Reduced
Blood products, collected from a donor with a history of male to male sex, were distributed.
Blood product, for which a unit received inadequate additive solution, was distributed.
American Natl. Red Cross-Greater Chesapeake & Potomac Region
American National Red Cross (The) - North Central Region
Blood products, with a high platelet yield, were distributed.
EXO Cricket Protein Bar Peanut Butter and Jelly; Net Wt 2.1 Oz. packaged in a film wrapper, 12 units per case; UPC: 861703000014
EXO Cricket Protein Bar Apple Cinnamon; Net Wt. 2.1 Oz. packaged in a film wrapper, 12 units per case; UPC: 861703000014
EXO Cricket Protein Bar Blueberry Vanilla; Net Wt 2.1 Oz. packaged in a film wrapper, 12 units per case; UPC: 861703000069
Product was only distributed to one customer in the Kentucky.
Chicken bacon, egg white and cheese on flat bread sandwich
The chicken bacon, egg white and cheese on flat bread sandwich was manufactured using a raw chicken bacon.
Buenas Grated coconut - frozen;  Kinayod na Niyog  Noix de Coco Rape;  UPC: 4806514650443  Keep Frozen  Net Wt. 16 oz., (4545 g) plastic bag    Product of the Philippines    Ingredients: Grated coconut Meat (95%) Water and preservative: Sodium Benzoate.
Salmonella found in one lot of grated coconut though sampling and testing by the California Department of Public Health
Scotcharoo product is recalled because the Contains statement does not declare Milk and Soy. Whey, Milk, and Soy Lecithin are declared in the Ingredients statement.
No Lot number or Expiration Date on package
ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet Brands, Fort Lauderdale, FL  33316, UPC 8 54049 00358 0.
CGMP Deviations: finished products were manufactured with poor quality water.
WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA  91710, UPC 7 66670 03988 6.
Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland
Brilliance 64 with 4.1.7 XX026 software version model number 728231    Product Usage:  Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
Surview scan with tube current lower than 30 mA is unable to be initialized.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Worldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.
MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035    Product Usage:  The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Control Console software has been updated to reduce the risk for collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table.
ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912    Product Usage:  The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
ONCOR Expression, Digital Linear Accelerator, Model No. 07360717    Product Usage:  The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472    Product Usage:  The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
PRIMUS HI, Digital Linear Accelerator, Model No. 04504200    Product Usage:  The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
ONCOR Impression , Digital Linear Accelerator, Model No. 05857920    Product Usage:  The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Product was distributed in the following states:  AL, CA, FL, HI, IA, IL, IN, KS, LA, MD, MI, MN, MO, MS, NC, ND, NE, NY, OH, OK, PA, TN, TX, VA & WI
HUNGRY JACK Original PANCAKE & WAFFLE MIX NET WT 32 OZ (2 LB) 907 g
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857
Defective Delivery System: Out of specification for adhesive transfer.
funky chunky Chocolate Pretzels.  Pretzels, Caramel, Chocolate, Pecans.  Sold in the following packaging configurations:    1.  Small Bag Net Wt. 2 oz. (56g) UPC 91056-00045;    2.  Large Bag Net Wt. 5 oz. (141g) UPC 91056-00040;     3.  Mini Canister Net Wt. 8 oz. (227g)  UPC 91056-00084;     4.  Mini Stack Gift Pack (includes 8 oz. Mini Canister Chocolate Pretzels);     5.  #1506 Mixed Case, Small Bags - 25/Case (includes 5- 2 oz. bags Chocolate Pretzels)  6.  Tasting Kit #1301 (includes 1-2oz. bag chocolate Pretzels)    Allergen Statement:  Contains:  Milk, Soy, Wheat, Pecans.  Manufactured in a facility that uses:  Milk, Soy, Wheat, Peanuts & Tree Nuts.  Funky Chunky LLC., Eden Prairie, MN  55344
Chocolate Pretzels are being recalled because the pecan pieces may contain undeclared tree nuts and peanuts.
Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Blood products, labeling/crossmatch tag incorrect or missing information were distributed.
American National Red Cross Southeastern Michigan Region
Misbranded Red Blood Cells, were distributed.
Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478
Formagere de la Brie brand, l' Explorateur, soft ripened cheese made from pasteurized milk, product comes in a 250g (8.8 oz), clear plastic package marked with lot # on the bottom, with UPC: 3 390010 004080.
The cheese has the potential to be contaminated with Listeria monocytogenes.
Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Walgreens Specialty Pharmacy Pittsburg, PA  Italy and Germany
Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 for Leadiant Biosciences, Inc. Gaithersburg, MD 20878, NDC 54482-020-01
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.