Recall Z-2111-2015— Covidien LLC

Name: FDA recall Z-2111-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-16

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2015-04-16, terminated 2017-06-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: Devon Light Gloves contain splits or holes compromising the sterility.

Recalling firm: Covidien LLC
Classification: Class II
Status: Terminated
Initiated: 2015-04-16
Terminated: 2017-06-28
Firm location: North Haven, CT, United States

Product description

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

Reason for recall

Devon Light Gloves contain splits or holes compromising the sterility

Data sourced from openFDA. This site is unofficial and independent of the FDA.