FDA Medical Device Recalls (openFDA)
American Contract Systems, Inc.: BASIN SET, MEBS42K, general surgical kit
- Recall number
- Z-0274-2023
- Recalling firm
- American Contract Systems, Inc.
- Product
- BASIN SET, MEBS42K, general surgical kit
- Status
- Terminated
- Initiated
- 2022-10-12
- Posted
- 2022-11-22
- Terminated
- 2025-03-06
- Reason
- Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.
- Root cause
- Employee error
- Action
- The firm issued an URGENT: MEDICAL DEVICE FIELD CORRECTION notice to their consignees by email on 10/12/2022. The notice explained the issue and requested the following actions be taken: "Please review your inventory, and segregate and quarantine all affected Kits. If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of this product recall and maintain records of effectiveness. If you received any of the batches listed in this notification letter, please contact Breah.Waldridge@owens-minor.com for a replacement kit."
- Quantity
- 1504 trays
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI/DI 00191072151742, Batch/Lot No. 833221, exp 6/16/2023
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- 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