Recall Z-2114-2015— Covidien LLC

Name: FDA recall Z-2114-2015
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: Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR 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

Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR 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.