FDA Medical Device Recalls (openFDA)
Medline Industries, Inc.: PICC Tray, STERILE, 12 packs each per case.
- Recall number
- Z-2977-2018
- Recalling firm
- Medline Industries, Inc.
- Product
- PICC Tray, STERILE, 12 packs each per case.
- Status
- Terminated
- Initiated
- 2017-04-12
- Posted
- not on file
- Terminated
- 2019-08-05
- Reason
- Multiple surgical packs were assembled with a non-sterile CHG disk labeled as BIOPATCH" (kit component #52655) attached to the outside of the sterile pack. This may pose potential risk of infection. However, the kits have been in distribution since March 2016. Many of these kits have been used with no reported infections or adverse patient events. In addition, the BIOPATCH is impregnated with CHG, a well-known antiseptic agent with broad-spectrum anti-microbial and antifungal activity.
- Root cause
- Under Investigation by firm
- Action
- Firm contacted customers via phone and letter beginning April 12, 2017. Customers were instructed to remove the Ethicon BioPatch Protective Disk with CHG from the kit(s) and return it to the firm. The firm would provide a sterile replacement BioPatch. Affected product will be destroyed.
- Quantity
- 144 kits
- Distribution
- CA, NM
- Lot, serial or model codes
- Item number: DYNJ49177C. Lots: 16HB4700, 16UB5076, 17MB6837
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 3000717925
- Firm city
- Waukegan
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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