Recall Z-2109-2015— Covidien LLC

Name: FDA recall Z-2109-2015
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: Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR 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

Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR 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.