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

Augmentation Kit , Sterile-.Kits containing the Devon Light Glove… — recall Z-2116-2015

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

As described by U.S. FDA — Device Enforcement: Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2116-2015
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
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution-US (nationwide) including the Virgin Islands and the countries of Canada, Australia, New Zealand, Costa Rica, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland , France, Germany, Netherlands, Sweden, Ireland, ISRAEL,Spain, Italy, Jordan, Kenya, Kuwait, United Kingd
Reported risk: Devon Light Gloves contain splits or holes compromising the sterility
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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