Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

BASIN SET, MEBS42K, general surgical kit

FDA Recall Z-0274-2023 · Posted 2022-11-22

Recalling FirmAmerican Contract Systems, Inc.
Recall StatusTerminated
Product CodeLRO
Date Initiated2022-10-12
Date Terminated2025-03-06
Product Quantity1504 trays

Reason for Recall

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.

Firm 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 [email protected] for a replacement kit."

Root Cause

Employee error

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑