Recalling Firm
Implant Direct Sybron Manufacturing, LLC
American National Red Cross (The) Carolinas Region
The American National Red Cross South Carolina Region
New York Blood Center, Inc. dba HBVS Elmsford Donor Center

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South
Nationwide Distribution including CA, CT, FL, IL, LA, ME, MI, NC, ND, NJ, NY, PA, RI, SC, VA
Worldwide including the countries of United States, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Great Britain, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, japan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Republic of Korea (S), Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, South Africa, Switzerland, Syria, Taiwan, Thailand, Trinidad-Tobago, Turkey, Turkmenistan, United Arab Emirates, Uruguay, Vatican, Venezuela,
Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD
USA (nationwide) Distribution to the states of: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, VA, WA, WI, and WV. Internationally to Canada. There was no military/government distribution.
Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY.
Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan.
Nationwide Distribution to AK, OH, TX, GA, and MI
Worldwide Distribution including France and Germany
AR, CO, CT, DE, FL, GA, IL, IN, KS, MA, MD, ME, MI, MO, MS, NC, NJ, NY, OH, PA, TN, TX, UT, VA, WI, WV
Worldwide Distribution - US Distribution and to the countries of : Belgium, Canada, France, Germany, Italy, Japan and S. Korea
Worldwide distribution including US nationwide and Canada, AE, AT, AU, BD, BE, BG, BR, CH, CL, CN, CY, DE, DK, EG, ES, FR, GB, HU, IE, IL, IN, IT, JO, JP, KW, KR, LB, MA, MX, MY, NL, NO, PA, PK, PL, PT, QA, RO, RU, SA, SE, SG, SK, Sri Lanka, TH, TW, UAE, UK, ZA,
Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA
The firm distributed product to the following Direct Accounts: 1). C&S Aberdeen, MD 2). C&S Giant, York, PA 3). C&S Westfield, MA 4). C&S Giant, York, PA 5). C&S Westfield, MA Please see attached excel spread sheet for detail list of Retail Stores.
U.S. distribution to the following: CA, HI, NV No foreign distribution.
Domestic: MI, OH, GA, AZ Foreign: Canada
Domestic: IN, MI, NY Foreign: None VA/DOD: None

Product Description
BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for Staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. --- Product is packaged 25 panels to 1 box.
Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD
Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.
Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD
Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High);
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring
Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node
Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physicians choice of treatment. It is indicated for patients having difficulty with secretion clearance or the presence of atelectasis caused by mucus plugging.
Berry Flavor Immune Support Dietary Supplement Effervescent Tablets 10 Tablets/bottle. Product is sold under the following brand names: Discount Drug Mart UPC 0 93351 01230 3; Good Neighbor Pharmacy UPC 0 87701 41330 8; Hyvee UPC 0 75450 09537 1; Kinray Preferred Plus UPC 0 23513 01010 6; Live Better UPC 0 41310 62998 7; Meijer UPC 7 08820 15073 7; Premier Value UPC 8 40986 02972 1; QC UPC 6 35515 96938 4; Rite Aid UPC 0 11822 95098 5; Shopko UPC 4 00114 22672 1; ShopRite UPC 0 41190 22784 6; Top Care UPC 0 36800 40632 2 & UPC 0 36800 40632 2; Western Family UPC 0 15400 12657 1 & Winco UPC 0 70552 24153 4.
Orange Flavor Immune Support Dietary Supplement Effervescent Tablets 10 Tablets/bottle. Product is sold under the following brand names: Best Choice UPC 0 70038 60863 9 & UPC 0 70038 60863 9; Discount Drug Mart UPC 0 93351 00909 9; Freds Mart UPC 0 84579 12451 0; Good Neighbor Pharmacy UPC 0 87701 40672 0; Health Accents UPC 7 25439 95738 0; Health Mart UPC 0 52569 14073 4; Hyvee UPC 0 75450 06187 1; Kinray Preferred Plus UPC 0 23513 81512 1; Leader UPC 0 96295 13167 3 & UPC 0 96295 12239 8; Live Better UPC 0 41310 62997 0; Meijer UPC 7 08820 15072 0; Premier Value UPC 8 40986 01982 1; QC UPC 6 35515 95513 4; Reese UPC 0 23513 81512 1; Rite Aid UPC 0 11822 45092 8; Select Brand UPC 0 15127 02433 4; Shopko UPC 4 00125 10186 4; ShopRite UPC 0 41190 22785 3; Top Care UPC 0 36800 38123 0 & UPC 0 36800 38123 0; Western Family UPC 0 15400 12656 4 & Winco UPC 0 70552 24154 1.
Gamma Green tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles
Pretty purple tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles
Royal Blue Glycerin Tattoo Ink packaged in 1oz, 2oz, 4oz, 8oz bottles
Orange color tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles
Light Blue tattoo ink packaged in 1oz, 2oz, 4oz, 8oz bottles
No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by NEW RELIANCE TRADING, INC., 5563 59th St., Maspeth, New York, 11378-2358, UPC 8993138993349, 5842109854239.
Pooled Platelets, Leukocytes Reduced, Irradiated
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate
The Toothsome Chocolate Emporium Dark Chocolate Peanuts. The affected product is packaged in 8 oz. clear bag within a gold Toothsome Chocolate Emporium box, 24/case
The Toothsome Chocolate Emporium Dark Chocolate Cranberries. The affected product is packaged in 8 oz. clear bag within a gold Toothsome Chocolate Emporium box, 24/case
The Toothsome Chocolate Emporium Dark Chocolate Coffee Beans. The affected product is packaged in 8 oz. clear bag within a gold Toothsome Chocolate Emporium box, 24/case
Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three-dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumber vertebrae with a posterior approach.
GourmetNut DARK CHOCOLATE COVERED ALMONDS NET WT 7oz (198g); UPC: 708747152203
Dark Chocolate Cashew, Net 11 oz., Contains Cashew and Soy, Distributed By: Dutch Valley Food Distributors, Inc., Myerstown, PA 17067; UPC: 77245 00601; Lot#, Best By dates: 20160404, 04/14/17;
BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers.
Trace Mineral SALT BLOCK, NET WT 50 LB (22.7 KG), UPC code: 1360001945
Wegmans Organic Dark Chocolate Covered Cranberries NET WT 14 OZ (396g) UPC: 0 77890 37786 4, Product code 5546289
Organic Dark Chocolate (Covered) Cherries: Wegmans Organic Dark Chocolate Cherries NET WT 14 OZ (396g), UPC: 0 77890 37785 7, Product code 5546290 and TOPS snacks Organic Dark Chocolate covered Cherries NET WT 13 OZ (368 g) UPC: 0 70784 50779 8, Product code 5541417
Organic Dark Chocolate (Covered) Raisins; Wegmans organic Dark Chocolate Covered Raisins NET WT 14 OZ (396g), UPC: 0 77890 37787 1, Product code 5546291
Party Tray: Yorgo's Foods PARTY TRAY ORIGINAL HOMMUS NET WT. 32 OZ UPC: 7 56248 10097 1 and Yorgo's Foods PARTY TRAY RED PEPPER HOMMUS NET WT. 32 OZ UPC: 7 56248 10016 2. Product is packaged in a clear plastic container, keep refrigerated.
Yorgo's Foods FALAFEL NET WT. 5 LBS 80 oz (2268g). Product is packaged in a clear plastic container, keep refrigerated.
Yorgos FOODS Roasted Red Pepper Hommus 8 oz. (227g) UPC: 7 56248 10016 2 and 16 oz. (454g) UPC: 7 56248 10017 9 and NET WT. 5 LBS 80 oz (2268g). Product is packaged in a clear plastic container, keep refrigerated.
Yorgos FOODS Original Hommus 8 oz. (227g) UPC: 7 56248 10002 5 and 16 oz. (454g) UPC: 7 56248 10005 6; 32 OZ UPC: 7 56248 10010 0; NET WT. 5 LBS 80 oz (2268g) UPC: 7 56248 10100 8. Product is packaged in a clear plastic container, keep refrigerated.
Yorgo's Foods THREE BEAN SALAD NET WT. 5 LBS 80 oz (2268g) UPC: 7 56248 10071 1 and Yorgo's THREE BEAN SALAD NET WT. 12 OZ (340g) UPC: 7 56248 10063 6. Product is packaged in a clear plastic container, keep refrigerated.
Yorgos FOODS Baba Ghannouj UPC: 7 56248 10006 3; Yorgo's Foods BABA GHANNOUJ NET WT. 16 OZ (454g) UPC: 7 56248 10006 3 - Product is packaged in a clear plastic container, keep refrigerated. Yorgo's Foods BABA GHANNOUJ NET WT. 5 LBS 80 oz (2268g)
Yorgo's Foods GRAPE LEAVES NET WT 8 OZ (227g) UPC: 7 56248 10004 9; Yorgo's Foods GRAPE LEAVES NET WT. 5 LBS 80 oz (2268g). Product is packaged in a clear plastic container, keep refrigerated.
Yorgos FOODS Green Olive Hommus NET WT 8 OZ (227g) UPC: 7 56248 10032 2. Product is packaged in a clear plastic container, keep refrigerated.
Yorgo's Foods BLACK BEAN SALAD NET WT. 5 LBS 80 OZ (2268g) UPC: 7 56248 10069 and Yorgo's Foods BLACK BEAN SALAD NET WT. 12 OZ (340g)UPC: 7 56248 10062 9. Product is packaged in a clear plastic container, keep refrigerated.
Yorgo's Foods GARLIC AND CHIVE HOMMUS NET WT 8 OZ (227g) UPC: 7 56248 10034 6. Product is packaged in a clear plastic container, keep refrigerated.
Tahini Sauce: TRADER JOE S TAHINI SAUCE NET WT 8 OZ (227g) UPC: 0078 7239; Yorgo's Foods TAHINI SAUCE NET WT. 5 LBS 80 OZ (2268g)Product is packaged in a clear plastic container, keep refrigerated.
Yorgos FOODS Lemon Hommus UPC: 7 56248 10018 6. Product is packaged in a clear plastic container, keep refrigerated.
Yorgo's Foods SUNDRIED TOMATO and BASIL HOMMUS NET WT 8 OZ (227g) UPC: 7 56248 10031 5. Product is packaged in a clear plastic container, keep refrigerated.
Yorgo's Foods TZATZIKI NET WT 8 OZ (227g) UPC: 7 56248 10053 7 and Yorgo's Foods TZATZIKI NET WT. 5 LBS 80 oz (2268g). Product is packaged in a clear plastic container, keep refrigerated.
Yorgo's Foods CHIPOLTE PEPPER HOMMUS NET WT 8 OZ (227g) UPC: 7 56248 10019 3. Product is packaged in a clear plastic container, keep refrigerated.
Yorgo's Foods CHICKPEA SALAD NET WT. 5 LBS 80 OZ (2268g) UPC: 7 56248 10068 1 and Yorgo's Foods CHICKPEA SALAD NET WT. 12 OZ (340g)UPC: 7 56248 10061 2. Product is packaged in a clear plastic container, keep refrigerated.
Yorgos FOODS Garlic Hommus 8 oz. (227g) UPC: 7 56248 10015 5 and 16 oz. (454g) UPC: 7 56248 10014 8. Yorgo's Foods GARLIC HOMMUS NET WT. 5 LBS 80 OZ (2268g) Product is packaged in a clear plastic container, keep refrigerated.
Yorgo's Foods VEGETABLE HOMMUS NET WT 8 OZ (227g) UPC: 7 56248 10008 7 and Yorgo's Foods VEGETABLE HOMMUS NET WT. 5 LBS 80 OZ(2268g). Product is packaged in a clear plastic container, keep refrigerated.
Yorgo's VEGAN HOPPIN SALAD NET WT. 12 OZ (340g) UPC: 7 56248 10064 3. Product is packaged in a clear plastic container, keep refrigerated.
Yorgos FOODS Spinach & Artichoke Hommus - UPC: 7 56248 10067 4. Product is packaged in a clear plastic container, keep refrigerated.
Yorgo's Foods TABOULE SALAD NET WT. 5 LBS 80 oz (2268g) UPC: 7 56248 10057 5; Yorgo's Foods TABOULE SALAD NET WT 7 OZ (198.4g) UPC: 7 56248 10001 8; Yorgo's Foods TABOULE SALAD NET WT 14 OZ (397g) UPC: 7 56248 10007 0; Product is packaged in a clear plastic container, keep refrigerated.
Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA
Red Blood Cells, Leukocytes Reduced, Irradiated
Blood and Blood Products for Reprocessing
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF 400-0100.08; CORE Mobile Imaging System Refurbished REF 400-0100.08-R; CORE Imaging System REF 400-0100.02 For intravascular ultrasound imaging.
Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.
Ahold-Own Brands Whole Kernel Sweet Corn, 16 oz. Plastic Bag : Stop & Shop Brand Frozen Whole Kernel Sweet Corn, 16 oz. GIANT/MARTIN S Brand Frozen Whole Kernel Sweet Corn, 16 oz. Giant Brand Frozen Whole Kernel Sweet Corn, 16 oz.
Casa Sanchez Foods, Real Guacamole; Net Wt. 9 oz.. (255 g), 1/2 gallon UPC: 0 78732 00412 2; 78732 00431-3 ; 0-78732-00412-2 Ingredients: Avocados, tomatoes, cucumber, onions, pepper, lemon juice, sea salt, ascorbic acid and citric acid.
Casa Sanchez Foods, Spicy Guacamole; Net Wt. 9 oz.. (255 g) UPC: 0 78732 00426 9
Bean Boy Coffee Dark Chocolate Covered Espresso Beans
Maple Hill Creamery, Fiore Di Latte Fresh Mozzarella; 8-oz. (227g); UPC: 855088005474
pure encapsulations AI Enzymes DIETARY SUPPLEMENT 120 CAPSULES UPC: 7 66298 00318 4 and 60 CAPSULES UPC: 7 66298 00317 7
Pure Encapsulations Systemic Enzyme Complex DIETARY SUPPLEMENT 180 CAPSULES UPC: 7 66298 00862 2
Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0.
Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534

Product Quantity
840 blocks (80 pallets x 40 blocks per pallet)

Reason for Recall
BD has recently confirmed quality control failures, related to a manufacturing issue, for the inducible macrolide-linosamide-streptogramin B (iMLSb) test contained on lot 7031818 of Phoenix panels. The iMLSb resistance D-test screen for Staphylococcus species is used to identify phenotypic drug resistance to clindamycin and erythromycin. As the product should not be used when quality control (QC) fails, it is unlikely that there would be any impact on patient results, however, if a customer does not perform QC testing and uses the panel, there is a potential to incorrectly treat a Staphylococcus infection with clindamycin based on the iMLSb test result. This issue can be detected 100% of the time when used per package insert instructions with iMLSb positive strain S. aureus BAA-977.
Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER).
Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with various lots of N Protein Standard SL. N/T Protein Controls SL for Ceruloplasmin are similarly biased. --- The affected standards and controls for the affected lots were incorrectly value assigned, which led to a lower result compared to correctly assigned standards. Note: N Antiserum to Human Ceruloplasmin (REF OUIE) works as intended. --- Siemens investigation indicated that N Protein Standard SL and corresponding N/T Protein Control SL (Levels Low, Mid and High) are inaccurately assigned for Ceruloplasmin.
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.
Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subject to an EMI if they come into direct contact with the Monarch device.
Blood products, collected from an ineligible donor, were distributed.
Pooled Platelet products, not manufactured according to specifications, were distributed.
One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.
The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
RUCKER S MAKIN BATCH CANDIES (RMBC) initiated a voluntary recall of The Toothsome Chocolate Emporium Dark Chocolate Coffee Beans, Dark Chocolate Cranberries, and Dark Chocolate Peanuts following supplier's recall due to undeclared allergen milk.
A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.
Our supplier, GKI, did not have milk declared as an allergen on an item we repackage. Therefore our labels did not contain milk
Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.
Selenium level in the referenced lot is above specification and does not meet labeled specifications.
Product may be contaminated with Listeria monocytogenes.
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Blood products collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood product, labeled with an incorrect expiration date, was distributed.
Blood product in which routine testing/testing performed, interpreted, or documented incorrectly, was distributed.
On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during use, and the users response to the dialog may adversely affect the subsequent operation of the device.
Stent length on the label may not match the length of the stent itself.
Ahold U.S.A., Inc. was notified by the Virginia Department of Agriculture that one of three retail samples of Whole Kernel Corn, 16 oz. tested positive for Listeria Monocytogenes on 11/13/2017. The firm has decided to initiate a recall of the product .
FDA found Listeria monocytogenes in surveillance sample of guacamole.
Pacific Rim Distribution Inc., dba Bean Boy Coffee is voluntarily recalling Dark Chocolate Covered Espresso Beans following a supplier's recall due to undeclared allergen milk.
Visible spoilage of product before the end of shelf life.
CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Apheresis product, collected from a donor who was allowed to donate without a current physical, was distributed.
Blood product, collected from a donor who was allowed to donate without a current physical, was distributed.
Blood products, collected from a donor who was allowed to donate without a current physical, were distributed.
S&M Products Inc. dba Steve's Gourmet Confections initiated a voluntary recall of Dark Chocolate Banana Chips and Dark Chocolate Almonds due to supplier's recall for undeclared allergen milk.

Code Info
UPC 400013041067, 400013041098 and 400013041098. This only affects packages with best by codes ranging from 05/11/17 thru 10/09/18
Potentially affected are ExacTrac Vero versions 3.x. Currently only ExacTrac Vero SW versions 3.5(.x) are installed for use on existing ExacTrac Vero Systems (only ExacTrac Vero v.3.5 exist in the field). UDI: 04056481132446
Lot 29517AOMAA Material number: 100012623 UPC code: 1360001945
Best by Oct 2019 B7 276 2. Produced in Canada Stop & Shop Brand Frozen Whole Kernel Sweet Corn, 16 oz., UPC 68826700676 GIANT/MARTIN S Brand Frozen Whole Kernel Sweet Corn, 16 oz., UPC 68826700676 Giant Brand Frozen Whole Kernel Sweet Corn, 16 oz., UPC 68826700676
UPC 0-78732-00412-2 Lot Code 276, Expiration Date 11/07/17 Lot Code 277, Expiration Date 11/08/17 Lot Code 278, Expiration Date 11/09/17 Lot Code 279, Expiration Date 11/10/17 Lot Code 282, Expiration Date 11/13/17 Lot Code 283, Expiration Date 11/14/17 Lot Code 284, Expiration Date 11/15/17 Lot Code 285, Expiration Date 11/16/17 Lot Code 289, Expiration Date 11/20/17 Lot Code 290, Expiration Date 11/21/17 Lot Code 291, Expiration Date 11/22/17 Lot Code 292, Expiration Date 11/23/17 Lot Code 293, Expiration Date 11/24/17 Lot Code 296, Expiration Date 11/27/17 Lot Code 300, Expiration Date 12/01/17 Lot Code 303, Expiration Date 12/04/17 Lot Code 306, Expiration Date 12/07/17 Lot Code 310, Expiration Date 12/11/17 Lot Code 313, Expiration Date 12/14/17 Lot Code 317, Expiration Date 12/18/17 Lot Code 318, Expiration Date 12/19/17 UPC 0-78732-00431-3 Lot Code 275, Expiration Date 11/16/17 Lot Code 276, Expiration Date 11/17/17 Lot Code 285, Expiration Date 11/26/17 Lot Code 289, Expiration Date 11/30/17 Lot Code 313, Expiration Date 12/19/17 UPC 0-78732-00412-2 Lot Code 285, Expiration Date 11/01/17 Lot Code 289, Expiration Date 11/05/17 Lot Code 292, Expiration Date 11/07/17 Lot Code 300, Expiration Date 11/16/17 Lot Code 306, Expiration Date 11/22/17 Lot Code 313, Expiration Date 11/29/17 Lot Code 317, Expiration Date 12/03/17
UPC 0-78732-00426-9 Lot Code 276, Expiration Date 11/07/17 Lot Code 277, Expiration Date 11/08/17 Lot Code 278, Expiration Date 11/09/17 Lot Code 284, Expiration Date 11/15/17 Lot Code 285, Expiration Date 11/16/17 Lot Code 289, Expiration Date 11/20/17 Lot Code 291, Expiration Date 11/22/17 Lot Code 296, Expiration Date 11/27/17 Lot Code 310, Expiration Date 12/11/17 Lot Code 313, Expiration Date 12/14/17 Lot Code 318, Expiration Date 12/19/17
UPC Code 045635427075, Expiration Dates Apr 2018 Jun 2019
Lot #: 609124, Exp 03/18 Manufacturing batches were mfg at Delta Laboratories under Batch Number 511103 11/16/2015 Batch Number 609124 09/21/2016
Dark Chocolate Banana Chips, 12 oz., UPC: 091037443540, Product with expiration from 07/14/2016 through 11/3/2018
Dark Chocolate Almonds, 6 oz. and Bulk, no UPC or Expiration date provided. No labeling was provided.