Recall Z-2116-2015— Covidien LLC

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: Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation 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

Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation 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.