FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
- Recall number
- Z-1690-2023
- Recalling firm
- Cardinal Health 200, LLC
- Product
- Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
- Status
- Open, Classified
- Initiated
- 2023-04-06
- Posted
- 2023-06-06
- Terminated
- not on file
- Reason
- Inadvertently released for distibution without sterility assurance.
- Root cause
- Process control
- Action
- Cardinal Health initially notified customer on 04/06/2023, via telephone, on 04/12/2023, via email and followed up with a recall notification letter on 05/05/2023. Customer was instructed to return affected product.
- Quantity
- 5 units
- Distribution
- Distribution in the US to Georgia
- Lot, serial or model codes
- Catalog Number: SMA21LPUHJ; Lot Number: 019693
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHD
- Firm FEI
- 3001236905
- 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