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

Recall Z-1182-2023 — Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK

U.S. FDA — Device Enforcement · United States · 2022-12-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1182-2023
Date of alert
2022-12-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien, LP
Product category
device
Product type
Devices
Reported risk: Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.