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

Recall Z-2111-2015 — ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit

U.S. FDA — Device Enforcement · United States · 2015-04-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2111-2015
Date of alert
2015-04-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
50000511
Reported risk: Devon Light Gloves contain splits or holes compromising the sterility
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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