—#196685

Product

BASIN SET, MEBS42K, general surgical kit

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI/DI 00191072151742, Batch/Lot No. 833221, exp 6/16/2023

Why it was recalled

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 (FDA determination)

Employee error

Action the firm took

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."

Recalling firm

Firm: American Contract Systems, Inc.
Address: 2610 Ne Industrial Dr, Ste 220, Kansas City, Missouri 64117-2648

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2022-10-12
Posted by FDA: 2022-11-22
Terminated: 2025-03-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196685. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.