FDA Medical Device Recalls (openFDA)
Medical Action Industries, Inc. 306: Kit: Central Line Dres Change 20/Cs
- Recall number
- Z-0147-2022
- Recalling firm
- Medical Action Industries, Inc. 306
- Product
- Kit: Central Line Dres Change 20/Cs
- Status
- Terminated
- Initiated
- 2021-09-08
- Posted
- not on file
- Terminated
- 2023-10-13
- Reason
- The ChloraPrep 3ml kit component has a shorter expiry date than the labeled kit expiry date.
- Root cause
- Process control
- Action
- A customer email was sent to the impacted distributor dated 09/16/2021. The distributor was notified of the recall issue and instructed to inventory and segregate affected product. Warning labels were provided and are to be affixed to the affected kits. Relabeling should be conducted in a manner that does not allow other pertinent labeling information to be covered up. The distributor was also notified that the recall should be carried out to the end user level.
- Quantity
- 42 cases
- Distribution
- Distribution to a single US distributor in Michigan
- Lot, serial or model codes
- Product Code: 59815B, Batch 0000285665; Kit expiration date 03/31/2024 UDI: 20809160170523
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PEZ
- Firm FEI
- 1030451
- Firm city
- Arden
- Firm state
- NC
- 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