MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item No. Lot No. Expiration Date, CBN1106 12113H10A Oct-15, CBN1106 13033H10A Feb-16, CBN1106 13053H10A Apr-16, CBN1106 13083H10A Jul-16, CBN1106 13103H10A Sep-16, CBN1106 13113H10A Oct-16, CBN1106 14013H10A Dec-16, CBN1106 14043H10A Mar-17, CBN1106 14053H10A Apr-17, CBN1106 14063H10A May-17, CBN1106 14083H10A Jul-17, CBN1106 14093H10A Aug-17, CBN1106 14093H10A Aug-17, CBN1106 14113H10A Oct-17, CBN1106 14123H10A Nov-17, CBN1106 15013H10A Dec-17, CBN1106 15023H10A Jan-18, CBN1106 15033H10A Feb-18, CBN1106 15043H10A Mar-18, CBN1106 15053H10A Apr-18, CBN1106 15063H10A May-18, CBN1106 15083H10A Jul-18, CBN1106 15073H10A Jun-18.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Owens & Minor Distribution, Inc.
- Reason for Recall:
- MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.
Product Codes/Lot Numbers:
Item No. Lot No. Expiration Date, CBN1106 12113H10A Oct-15, CBN1106 13033H10A Feb-16, CBN1106 13053H10A Apr-16, CBN1106 13083H10A Jul-16, CBN1106 13103H10A Sep-16, CBN1106 13113H10A Oct-16, CBN1106 14013H10A Dec-16, CBN1106 14043H10A Mar-17, CBN1106 14053H10A Apr-17, CBN1106 14063H10A May-17, CBN1106 14083H10A Jul-17, CBN1106 14093H10A Aug-17, CBN1106 14093H10A Aug-17, CBN1106 14113H10A Oct-17, CBN1106 14123H10A Nov-17, CBN1106 15013H10A Dec-17, CBN1106 15023H10A Jan-18, CBN1106 15033H10A Feb-18, CBN1106 15043H10A Mar-18, CBN1106 15053H10A Apr-18, CBN1106 15063H10A May-18, CBN1106 15083H10A Jul-18, CBN1106 15073H10A Jun-18.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0735-2016
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Owens & Minor is the initial importer and private label distributor of Medi Choice Arm Slings (Product). The Product is manufactured in China by Tops Medical Articles Nantong Inc. Owens & Minor first learned of the product issue that prompted the product removal action via customer complaints received in September 2016. Two customer complaints received on September 1"1, 2016 reported surface contamination on the arm slings. Two additional complaints reported on September 19, 2016 and October 7, 2016 reported the same issue. Upon receipt of the complaints on September 1, 2016, Owens & Minor immediately initiated a CAPA investigation for root cause analysis and determination of corrective/preventive actions. A quality inspection of inventory confirmed that the surface contamination was confined to lots manufactured in May, June, and July of 2016. The surface contamination for these lots was found to be frequent. Subsequent August product lots were inspected and no surface contamination was found. Limited inventory from lots prior to May 2016 were available and inspected as well. No surface contamination was found on these prior lots. Owens & Minor has quarantined the affected product lots. The product is on hold at all Owens & Minor Distribution Centers (DC). Samples of contaminated product have been sent to the manufacturer for evaluation and to a certified testing lab for identification of contaminate. These results are pending at this time. Based on the frequency of the product defect as well as evaluation of potential adverse health event risk, Owens & Minor initiated a voluntary recall for the above stated affected product lots.