Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0503-2023 — HENRY SCHEIN, Vein Clinics 1, Item No.570-1426

U.S. FDA — Device Enforcement · United States · 2022-11-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0503-2023
Date of alert
2022-11-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stradis Medical, LLC dba Stradis Healthcare
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
22257490682
Reported risk: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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