The Recall Desk
HighFDA (Devices)·Z-0733-2016·Announced 2016-02-10

Owens & Minor Recalls MediChoice Cohesive Bandages Due to Microbial Contamination

Owens & Minor is recalling MediChoice sterile cohesive bandages because testing revealed microbial contamination. The affected products were distributed nationwide.

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 Class II medical device with microbial contamination, which poses a risk of harm but does not meet the criteria for Class I (death/serious injury) or Severe (hospitalization reports).

Plain-English summary

Owens & Minor Distribution, Inc. is recalling MediChoice sterile cohesive bandages. The recall was initiated after testing indicated that the bandages were contaminated with microorganisms. The affected products are sold under a private brand and are intended for general hospital use.

The recall covers 42,050 units of the bandages, which were distributed nationwide. The specific lot numbers and expiration dates for the affected items range from October 2015 to July 2018. The product is packaged as one roll of cohesive bandage per bag, with thirty-six bags per case.

Healthcare facilities and consumers should stop using the affected bandages and contact Owens & Minor for instructions on how to return the products. The recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

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 — Wound Care
Hazard
Affected units
42,050

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 (18)

  • Item No. Lot No. Expiration Date: CBN1103 12113H08A Oct-15
  • CBN1103 13033H08A Feb-16
  • CBN1103 13053H08A Apr-16
  • CBN1103 14013H08A Dec-16
  • CBN1103 14043H08A Mar-17
  • CBN1103 14053H08A Apr-17
  • CBN1103 14083H08A Jul-17
  • CBN1103 14063H08A May-17
  • CBN1103 15013H08A Dec-17
  • CBN1103 14123H08A Nov-17
  • CBN1103 14113H08A Oct-17
  • CBN1103 15023H08A Jan-18
  • CBN1103 15033H08A Feb-18
  • CBN1103 15043H08A Mar-18
  • CBN1103 15053H08A Apr-18
  • CBN1103 15063H08A May-18
  • CBN1103 15073H08A Jun-18
  • CBN1103 15083H08A Jul-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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