The Recall Desk
HighFDA (Devices)·Z-0735-2016·Announced 2016-02-10

MediChoice Cohesive Bandages Recalled for Microbial Contamination

Owens & Minor is recalling MediChoice sterile cohesive bandages because testing revealed microbial contamination.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with microbial contamination, which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Owens & Minor Distribution, Inc. is recalling MediChoice sterile cohesive bandages. The product is imported and sold under a private brand. The recall was initiated because the bandages were tested and found to have microbial contamination.

The affected product consists of one roll of cohesive bandage per bag, with thirty-six bags per case. The bandages are intended for general hospital use. The recall covers 64,011 units distributed nationwide.

Consumers and healthcare facilities should stop using the affected bandages and contact Owens & Minor for further instructions.

The recalled product

Product
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.
Manufacturer
Owens & Minor Distribution, Inc.
Category
Medical Device — Bandages
Hazard
Affected units
64,011

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Owens & Minor Distribution, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Owens & Minor Distribution, Inc.

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Same hazard · microbial contamination

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