Recalling Firm
Zimmer Trabecular Metal Technology, Inc.
Meridian Medical Technologies a Pfizer Company
American National Red Cross Great Lakes Region

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

Distribution Pattern
The product was distributed to the following states: VA, TN. There are no government accounts for this recall. There are no Canada accounts for this recall. There are no Mexico accounts for this recall.
Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Product was distributed to one stable in KY.
Puerto Rico, Dominican Republic, US Virgin Islands, St. Maarten, St. Eustatius, Anguilla, St. Martin, St. Vincent, and Curacao
Nationwide and Puerto Rico, Argentina, Austria, Australia, Belgium, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Japan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Sweden, Switzerland, Taiwan, Thailand, United Kingdom. There has been no U.S. government or military distribution.
Nationwide, Sweden, Germany, New Zealand, Finland, Australia, Singapore, Korea, Luxembourg, Czech Republic, South Africa, Canada, Switzerland, United Arab Emirates, Spain, Austria, Hong Kong, Iceland, Japan, Canada, Italy, Ireland, France, United Kingdom
US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DE, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV
Product distributed to manufacturers in Illinois, Ohio, and Wisconsin.
Worldwide Distribution - US (Nationwide) Internationally to Canada, Australia, Brazil, Japan, Korea, Mexico, Bahrain, Egypt, Greece Hungary, Ireland, Israel, Jordan, Kazakhstan, Lithuania, Mauritius Namibia, Norway, Pakistan, Poland, Qatar, Romania, Russian Federation South Africa, Spain, Turkey, United Arab Emirates, United Kingdom Algeria, Armenia, Austria, Bahrain, Belarus, Belgium, Botswana Bulgaria, Cyprus, Czech Republic, Denmark, Egypt, Finland, France Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Kenya, Lebanon Lithuania, Macedonia, Malawi, Malta, Mauritius, Mozambique, Netherlands Norway, Oman, Poland, Portugal, Qatar, Republic of Moldova, Romania Saudi Arabia, Serbia, Slovakia, Sudan, Sweden, Switzerland, Tunisia Turkey, Uganda, Ukraine, United Kingdom, Yemen, and Zimbabwe
Worldwide Distribution - US Nationwide in the states of TX, FL, MO, NJ, WI, AL, TX, CA, OK, AZ, NC, GA, ID, WA, NY, NM and the countries of: Brazil, Canada, China, Taiwan, Canada, and Belgium.
ALDI stores in Alabama, Kentucky, Michigan, Mississippi, North Carolina, South Carolina, Tennessee and Virginia.
Product was shipped to the following states: MN, NY, OH, PA & WI.
Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela
US Distribution was made to medical facilities located in AL, FL, ID, LA, MO, NC, OK, SC, TX, and UT. There was government distribution and no foreign/military distribution.
US Distribution. This product has been sold to both distribution companies with multiple locations and directly to end users/hospitals in US.
US: AL, AZ, CT, FL, HI, IL IN, IA, KY, LA, ME, MI, MO, NJ,NY, OH, OR, PA, SC, TN, TX, VA, WA, WI. OUS; GERMANY, GREAT BRITAIN, POLAND, NETHERLANDS
Worldwide - US Nationwide in the countries of: Angola, Australia, Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Israel, Italy, Malaysia, Nambia, Netherlands, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, United Kingdom and Zambia
Distributed to the following states: DE, FL, MD, NC, NJ, NY, PA, TX, VA
Worldwide Distribution -US ( Nationwide) and Internationally to Canada, Costa Rica, Norway, Paraguay, Ireland, Panama, Ecuador, Hong Kong, Malaysia, Italy, UAE, Guatemala, Iceland, Indonesia, and Saudi Arabia.
Illinois, Michigan, Ohio, Virginia, and New Jersey
Worldwide Distribution -- US: CA, CO, CT, DE, GA, HI, IA, IL, KS, MA, MS, NC, NH, NM, NY, OH, PA, PR, RI, UT, VA, VT, WA, and WV; and, the countries of AE, BH, CA, CZ, FR, GB, HK, SA, and TR.
Worldwide Distribution - US Distribution to the state of : MA., and to the countries of : Canada, Netherlands, Dubai, Taiwan, Lebanon, Italy
US: AZ (shipped through Belgium to USA), MN, TN

Product Description
Ultralyx Nutritional Supplement 24% + 3% Mag Composite Block For Beef Cattle on Pasture, 200 lb. plastic tubs
Bearing Sleeve, 15CM Straight Taper Product Usage: Pneumatic system
eMax2 Hybrid Hand Control Product Usage: Electric system
Bearing Sleeve, 19CM Straight Taper Product Usage: Pneumatic system
IMRI SHORT HD ATTACHMENT Product Usage: Pneumatic system
Sagittal Saw Product Usage: Pneumatic system
Console, eMax2 Plus Product Usage: Electric system
B-SAGITTAL ASSEMBLY Product Usage: Pneumatic system
Minimal Access Attachment, BLACK MAX Product Usage: Pneumatic system
Foot Control, SC2100 Product Usage: Electric system
Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system
Otologic Curved Micro Product Usage: Pneumatic system
Autolube-III with 20ft hose Product Usage: Pneumatic system
11.0cm Long Attachment Product Usage: Pneumatic system
45 degree Contra Angle Attachment Product Usage: Pneumatic system
XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system
11cm QD Angle Attachment Product Usage: Pneumatic system
Minimal Access Attachment Product Usage: Pneumatic system
eMax2 PLUS Product Usage: Electric system
Adult Craniotome Product Usage: Pneumatic system
8.0cm Medium Attachment Product Usage: Pneumatic system
Autolube-III with Foot Guard Product Usage: Pneumatic system
14cm QD Angle Attachment Product Usage: Product attachment
14cm QD Angle Attachment Product Usage: Pneumatic system
10.5cm QD Angle Attachment Product Usage: Pneumatic system
Bearing Sleeve, 10CM Curved Product Usage: Pneumatic system
Foot control irrigation system Product Usage: Pneumatic system
Keyless Driver Product Usage: Pneumatic system
Bearing Sleeve, 15CM Straight Product Usage: Pneumatic system
Bearing Sleeve, 15CM Curved Product Usage: Pneumatic system
Bearing Sleeve, 10CM Straight Product Usage: Pneumatic system
20.2cm Heavy Duty Long Heavy Short Attachment
Electronic Foot Control with Direction Switch Product Usage: Electric system
90 degree Contra Angle Attachment Product Usage: Pneumatic system
Rotating Adult Craniotome Product Usage: Pneumatic system
8.2CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
6.5CM ADLT CRANI, THIN FT PLATE Product Usage: Pneumatic system
Oscillating MICRO-SAW Product Usage: Pneumatic system
XMAX Motor, High Strength Hose Product Usage: Pneumatic system
10.5cm Long Attachment, Non-Tapered End Product Usage: Pneumatic system
PEDIATRIC CRANIOTOME, BM Product Usage: Pneumatic system
System Console, Single Port, with irrigation Product Usage: Electric system
Minimal Access Straight Driver Product Usage: Pneumatic system
6.1CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
Autolube-III with NK Product Usage: Pneumatic system
7.2cm Adjustable Drill Guide Product Usage: Electric system
eMax2 Motor Assembly Product Usage: Electric system
IMRI SHORT ATTACHMENT Product Usage: Pneumatic system
Electric Handpiece EM Hand Control Product Usage: Electric system
IMRI AIR CONTROL Product Usage: Pneumatic system
Autolube-III with Irrigation Product Usage: Pneumatic system
12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system
10.5cm Long Attachment Product Usage: Pneumatic system
AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system
System Console, Single Port, no irrigation
Large Craniotome Product Usage: Pneumatic system
AL-III-DISS Adapter Product Usage: Pneumatic system
IMRI CRANI-A ATTACHMENT Product Usage: Pneumatic system
5.9CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
IMRI MOTOR Product Usage: Pneumatic system
8.0CM Heavy Duty Medium Attachment Product Usage: Pneumatic system
6.8cm Controlled Depth Attachment Product Usage: Pneumatic system
16cm Minimally Invasive Attachment Product Usage: Pneumatic system
Foot Control without Switches, SC2100 Product Usage: Electric system
19cm Attachment, Black Max Product Usage: Pneumatic system
Autolube-III Product Usage: Pneumatic system
12.6CM TAPERED ATTACHMENT, BLACK MAX Product Usage: Pneumatic system
AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system
BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS
MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.
Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., autoclavable; WA50042A Endoeye HD II, 10 mm, 30 deg., autoclavable; repair cable 10mm 0/30 deg., part number W7100603
Methocarbamol Suspension 100 mg/mL Suspension in a 500 mL white plastic bottle. UPC: 12/22/16-12/22/16
, GOYA FOODS, INC., Secaucus N.J. 07096.
Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807
The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.
EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.
EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS: Epipen Auto-Injector Jr. 0.15 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.
40/50 ct/kg (21/25 ct/lb) Farm Raised Head-On Shrimps, Keep Frozen, Must be fully cooked before serving. 1.02 kg, 2.24 lb. Packed by: Global Marketing Ent Inc, Chicago, IL 60616
Sysmex, Automated Hematology Analyzer XN Series, Sysmex Corporation, 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073 Japan
Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16
ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice.
Safeguard Flour product code 5122286 packaged in 50 lb bags
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs). The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
Life Rising Formulas SHT Chest Relief, 54 Capsules; Manufactured for: Nature's Health (USA) Chicago, IL 60616
MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the surgeon to follow in the excision of the lesion. Product Codes 47020, 475201, 477201,479201, and 470201 do not have the ultrasound enhancement shown in Figure 1. In addition,Product Codes 475201, 477201, 479201, and 470201 may be placed under MRI guidance. .
Clancys Snack Combo Pack 20 x 1 oz; Each 20 oz selling unit contains 4 x 1 oz bags of Original Potato Chips, 4 x 1 oz bags of Sour Cream & Onion Potato Chips, 4 x 1 oz bags of Barbecue Potato Chips, 3 x 1 oz bags of Nacho Tortilla Chips, 3 x 1 oz bags of Ranch Tortilla Chips, and 2 x 1 oz bags of Cheese Curls. Large 20 oz polyethylene plastic bag with drawstring handle containing twenty 1 oz units 4 retail Combo packs per case.
Trail's End Chicago Cubs Sweet and Savory Collection Trail's End Chicago Cubs Chocolate Lover's Collection Trail's End Chicago Blackhawks Collection Tin Snack mixes containing: Chocolate Caramel Corn; Chocolate Pretzels; White Chocolate Pretzels; White Cheddar Popcorn; Butter Toffee Caramel Corn. Tins contain 3-4, bags of the snack items listed, each bag ranging in size from 5oz. to 20oz.
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)
RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R, QTY: (1)
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)
RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)
RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)
RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)
RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)
RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)
Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located at the catheter tip, which are designed to provide independent infusion and aspiration functions for the active removal of fluid, excised tissue and thrombus from the peripheral treatment site.
AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 Product Usage: The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (488 nm) laser, two light scatter detection channels and electronic volume (EV).
Pre-cooked, chilled, Fresh Claw Crabmeat, 1 lb, packaged in plastic container with plastic lid. King Crab and Seafood De Venezuela, product of Venezuela.
Precooked, chilled, Fresh Jumbo Lump Crabmeat, 1 lb, packaged in plastic container with plastic lid. King Crab and Seafood De Venezuela, product of Venezuela.
Pre-cooked, chilled, Fresh Lump Crabmeat, 1 lb, packaged in plastic container with plastic lid. King Crab and Seafood De Venezuela, product of Venezuela.
Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation
Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation
H.E. B. brand Pomegranate Infused Cranberries COVERED IN Dark Chocolate, NET WT. 8 OZ. (227g), UPC CODE 041220985883
Nabelsi Thyme (also known on invoices as Zatar) 450g retail (24 packages per wholesale case) 4.5kg retail (2 bags per wholesale case) Cardboard box wholesale case, retail packages flexible plastic
Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Dressing Back, P/N 09810 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Dressing M/U XL, P/N 02344 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.
Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Allergy Relief, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072, UPC 3-59726-72025-0; (c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24, UPC 0-75450-12369-2; (d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24, UPC 3-59726-72025-0; (e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24, UPC 8-83967-39839-3.
Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle. Intended for use as a kit in special stain techniques.
Beyond Beef Feisty Crumble Vegan Gluten-free Non-GMO Weight: 10 lbs. (2) 5 lb. bags UPC: 10852629004412 KEEP FROZEN 111 Main Street El Segundo, CA 90245 866-756-4112 customer@beyondmeat.com www.beyondmeat.com; Beyond Meat Beyond Beef Crumbles Feisty Net WT 11oz (312g) KEEP FROZEN Plant Based Protein Crumbles UPC: 852629004132
Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.
Tropicana 100% JUICE, orange juice From Concentrate with Other Natural Flavors, 24-10 FL OZ (296 mL) BOTTLES, (TOTAL 240 FL OZ (1.8 GAL) 7L), UPC 48500 75823, Tropicana Manufacturing Company, Inc., Bradenton, Florida 34206 USA
Hand Crafted, LG Paleteria, La Granja, Mango Flavored Ice cream, Wt. 4 oz., in clear flexible plastic wrap.
Blood and Blood Products for Reprocessing
DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 018SNA- 018SND 0185NA 0185ND; INTERNAL CODE NUMBER: 0185TR- 0185NA- 018SND 0185NA 0185ND
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61
Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61
Source Naturals Dietary Supplement Vitamin D-3; Bioactive Form for Bone and Immune Health 2000 IU per serving, 500% DV. Other ingredients: Vegetable Glycerin, Deionized water, citric acid, Natural orange flavor and lemon essential oil. Use 5 drops once daily in a drink. Packed in glass bottles in the following sizes: Unit Size 1 fl. oz. (29.57 mL), UPC 0 21078 02274 9; 2 fl. oz. (59.14 mL) - UPC 0 21078 02275 6 4 fl. oz. (118.28 mL), UPC 0 21078 02276 3 glass bottles: Codes: 1 ounce glass bottle: SN2274; XUB078; 2 ounce glass bottle: SN2275; 4 ounce glass bottle: SN2276. Manufactured for: Source Naturals, Santa Cruz, CA.
Whole Foods Market Cold Pressed Juice, Apple; 16 FL. Oz. (1 pt) 473 mL. Keep refrigerated - Enjoy within 5 days of opening. UPC 8 13377 02154 3

Product Quantity
95 cases of 24(450g), 10 cases of 2 bags(4.5kg)
4665 cases (3856 retail packages/8366 food service packages)

Reason for Recall
Cattle deaths due to elevated levels of non-protein nitrogen.
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Product is suspect of drug contamination.
Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked.
Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it leads to battery depletion and pump shutdown.
A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.
Product label states name and ingredients as octopus and real content is squid.
This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was disseminated to distributors and sales representatives during the 2016 National Sales Meeting held February 17-21, 2016.
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Product label for frozen shrimp does not declare the presence of sulfites.
Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of salt deposits on unprotected electronic components may combust due to heat generated by electronics when instrument cycles. Completed CAPA identified the root cause as supplier providing defective component (sensor ready valve) and the misalignment of the electronic protective shield during manufacturing of the device.
When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may adversely affect the setup process resulting in an improper cushion setup. Sitting on an over inflated or under inflated Sensor Ready Cushion may reduce or eliminate the benefits provided by the cushion, increasing the risk to skin or to other soft tissue.
A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.
Product potentially contaminated with Salmonella
HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm.
Possible contamination of chili seasoning mix with Salmonella.
Product potentially contaminated with lead.
It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire.
Product has the potential to be contaminated with Salmonella
The firm was notified by a customer that they received product that was mislabeled due to undeclared peanuts.
The stability data does not support the product labeled with a 10-year shelf life.
after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small bias added to the CO2 measurement and affect the alarm notification.
According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A small percentage of the catheters in the affected lots may have damage to the ETFE catheter which may allow the catheter to break during withdrawal.
Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these units being mislabeled. Some 1.85mm JETSTREAM SC catheters may have been labeled as 2.1mm catheters, and some 2.1mm JETSTREAM XC catheters may have been labeled as 1.85mm catheters.
Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files.
Products may be contaminated with Listeria monocytogenes.
ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.
The product may contain undeclared almonds.
They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.
Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
One lot of Tropicana orange juice, may have small plastic fragments.
Plateletpheresis products, lacking proper quality control testing, were distributed.
Plateletpheresis products, lacking proper quality control procedures, were distributed.
The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight.
Blood products, for which the donor gave history which warranted deferral and was not deferred, were distributed.
Blood products, for which unit labeling was incorrect, were distributed.
Superpotent Drug; out of specification results for assay (manufacturer)
Testing of Vitamin D-3 as a result of a consumer complaint found specific lots to have lower concentrations than product specifications of ingredient labeling.
Platelet product, for which pH quality control testing did not meet specifications, was distributed.
Blood products, for which the donor health history screening questions were unanswered, were distributed.
Urban Remedy is voluntarily recalling Non-Dairy Spiced Golden Milk that was mislabeled as cold pressed apple juice. The ingredient list does not list tree nuts.

Code Info
All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREY-MIA16.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-15ST.
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. eMax2-HC.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-19ST.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-P.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-MRA-L.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0093; Part No. IMRI-SHORT-HD.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MM-SAGITTAL.
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. SC2100.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-SAGITTAL.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD11-S.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-D20BM.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-BLUE-S.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREY-ADG.
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. EPLUS-FP.
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-FP
All serial numbers shipped to customers; DFU 18-0062; Part No. B-MRA-S.
All product shipped prior to 09/27/2016; DFU 18-0040; Part No. BLACKMAX-N-LP
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-FP-DIR/RR
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0100; Part No. OCM.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD8.
All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-20
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0030; Part No. ORANGE-45.
All product shipped prior to 09/27/2016; DFU 18-0040; Part No. xMAX.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD11.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-ORANGE-90.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-D21.
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. EMAX2PLUS.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. Crani-A.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MEDIUM.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0097; Part No. CSR60BM.
All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-FG
All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD11.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. SHORT.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD14.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. R-SAW.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD8.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD11-S.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-10C.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREEN.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-BLACK.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. SHORT-HD.
All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AL-III-IRR
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. DRIVER.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-RED.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-15S.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-15C.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-10S.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. XL-HD.
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-FP-DIR.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. C-SYSTEM.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0030; Part No. ORANGE-90.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-L-R.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-A-R.
All serial numbers shipped to customers; DFU 18-0095; Part No. BM-DRIVER.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-Violet.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. S-SAW.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. SA-JACOBS.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD14-S.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD14-S.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD14.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-A-01.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. O-SAW.
All product shipped prior to 09/27/2016; DFU 18-0040; Part No. xMAX-H. Device Listing No. D015777.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-ORANGE-45.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-01.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-TURQ-X.
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. SC2101.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0099; Part No. MA-Driver.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-SILVER.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-GOLD.
All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-NK
All serial numbers shipped to customers; DFU 18-0048; Part No. ADG.
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. eMax2.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0093; Part No. IMRI-SHORT.
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-HC.
All product shipped prior to 09/27/2016; DFU 18-0093; Part No. IMRI-FOOT-CTRL
All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-IRR
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-HD.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. LONG-S.
All product shipped prior to 09/27/2016; DFU 18-0040 Part No. AL-III-DISS-30
All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREEN-R.
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. SC2102.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-L.
All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III-DISS
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0093; Part No. IMRI-CRANI-A.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-TURQUOISE.
All product shipped prior to 09/27/2016; DFU 18-0093; Part No. IMRI-MOTOR
All serial numbers shipped to customers; DFU 18-0062; Part No. B-MRA-M.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MEDIUM-HD.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CDA.
All serial numbers shipped to customers; DFU 18-0062; Part No. B-QD8-S.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0097; Part No. CSR60.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. MIA16.
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. SA-JLATCH.
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. EPLUS-FP-NS.
All product shipped prior to 09/27/2016; DFU 18-0062; Part No. BBLACK
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. QD8-S.
All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AUTOLUBE-III
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-TURQ-L.
All product shipped prior to 09/27/2016; DFU 18-0040; Part No. AL-III-DISS-20
Lots: LGOBA31154, LGOBA51153 Manufactured: 7/30/15 and 12/16/15
Lots: LGOJA33153, LGOJA02163 Manufactured: 8/12/15 and 1/13/16
US: lot 5GM631, exp. April 2017; lot 5GM640, exp. May 2017; lot 6GM072, exp. Sep 2017; lot 6GM082, exp. Sep 2017; lot 6GM088, exp. Oct 2017; lot 6GM087, exp. Oct 2017; lot 6GM198, exp. Oct 2017; lot 6GM081, exp. Sep 2017; lot 6GM091, exp. Oct 2017; lot 6GM199, exp. Oct 2017: INTERNATIONAL: lot 5FA665, exp. April 2017; lot 5GU763, exp. May 2017; lot 6FA293, exp. Oct 2017; lot 6FA292, exp. Oct 2017; lot 6GH294, exp. Oct 2017.
US lot 5GN767, expiration April 2017; lot 5GN773, expiration April 2017; lot 6GN215, expiration Sep 2017: INTERNATIONAL lot 5GR765, expiration March 2017; lot 5GK771, expiration April 2017; lot 5ED824, expiration April 2017; and lot 6ED117, expiration ***
Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android
All Newport Medical HT70 and HT70- Plus Ventilators
REYB1777 REZI0726 REZI0988 REZK0741 REZL0066 REAN0884
Expiration dates found on individual bags 7/18/2017 7/31/2017 8/1/2017
Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03
Lot Code # 030617WL, Use by Date: Sept 02 17
UPC code 0010439212, Dates of Expiration are 210218 (February 21, 2018) and 280218 (February 28, 2018).