FDA Medical Device Recalls (openFDA)
American Contract Systems, Inc.: Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
- Recall number
- Z-3233-2024
- Recalling firm
- American Contract Systems, Inc.
- Product
- Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
- Status
- Open, Classified
- Initiated
- 2024-08-07
- Posted
- 2024-09-24
- Terminated
- not on file
- Reason
- ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Root cause
- Under Investigation by firm
- Action
- Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " -Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION to its consignees on 08/07/2024 via email. The notice explained the issue, potential risk to health, and requested the following actions be taken: " Please review your inventory, and segregate and quarantine all affected Trays. If any of the affected trays identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. - Discard all affected kits and document on the enclosed Response Form."
- Quantity
- 18 units
- Distribution
- US Nationwide distribution in the states of MO, MN, MA, OH, NE.
- Lot, serial or model codes
- UDI-DI: 00191072178107; Lot: 2405102; Exp: 05/10/2025
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHD
- Firm FEI
- 3003419114
- Firm city
- Kansas City
- Firm state
- MO
- 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