Recall Z-2106-2015— Covidien LLC

Name: FDA recall Z-2106-2015
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: Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 3612 LIGHT GLOVE. 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

Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 3612 LIGHT GLOVE

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.