FDA Medical Device Recalls (openFDA)
Medline Industries, Inc.: BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.
- Recall number
- Z-2378-2018
- Recalling firm
- Medline Industries, Inc.
- Product
- BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.
- Status
- Terminated
- Initiated
- 2018-01-12
- Posted
- not on file
- Terminated
- 2020-07-22
- Reason
- One of the cases of product might not have been sterilized.
- Root cause
- Process control
- Action
- The recalling firm's sales representative telephoned their one customer on 1/12/2018 requesting return of the product.
- Quantity
- 6/5-kit cases
- Distribution
- The product was distributed to UT.
- Lot, serial or model codes
- Lot 17YM5936, Exp. 04/30/2019
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFF
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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