Owens & Minor Distribution, Inc.: 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.

Recall number

Z-0735-2016

Recalling firm

Owens & Minor Distribution, Inc.

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.

Status

Terminated

Initiated

2015-11-17

Posted

2016-01-30

Terminated

2016-09-13

Reason

MediChoice sterile cohesive bandages imported and sold under a private brand by Owens & Minor were tested and found to have microbial contamination.

Root cause

Under Investigation by firm

Action

The firms recall strategy is as follows : recall was initiated by the Owens & Minor Home Office Recall Officer. The Home Office Recall Officer e-mailed the following documents to the Distribution Center (DC) Recall Officer at each affected DC: 1. DC Recall Letter (specific instructions for the DCs), 2. Recall Inventory Report form (for the DCs to record the amount of affected product quarantined), 3. Customer Letter (specific instructions for the customers), 4. Recall Return Response Form (for the customers to report back the details of the quantity of affected product in their inventory), 5. Attachment 1 (a document that provides examples of the product labeling), 6. Recall Checklist (a checklist for the DCs listing the actions that need to be completed), and 7. Recall Combine Queries spreadsheet (listing customers and current on-hand inventory at the DCs). The DC Recall Officer at each DC forwarded the information to the DC Customer Service team. The DC Customer Service team notified each impacted customer via e-mail or letter based upon the customers recorded preference. Level to which the recall was initiated: The recall was initiated to the level of the customer (i.e., hospitals, clinics, surgery centers). Follow-up plans: A minimum of three (3) attempts are made to obtain an acknowledgment from the customer that they received the recall notification. An attempt to determine the status of non-responsive businesses will be made. If the non-responsive business is still viable, an attempt will be made to determine the employee responsible for management of recalls and the recall notice will be sent to that employee. If the business is no longer viable, the steps described below for out-of-business accounts will be followed. Sub-recall: No sub-recall is required. These products are supplied to User Facilities and not distributed to commercial sub-accounts. Plans for effective checks: 1. Check records to ensure that the initial recall not

Quantity

64011

Distribution

Nationwide Distribution.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

KGX

Firm FEI

3003753847

Firm city

Mechanicsville

Firm state

VA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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