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

Recall Z-0169-2022 — REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US

U.S. FDA — Device Enforcement · United States · 2021-09-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0169-2022
Date of alert
2021-09-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
W L Gore & Associates, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
22689696
Reported risk: Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
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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