Recall Z-1997-2014— Covidien LLC

Name: FDA recall Z-1997-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-08

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2014-05-08, terminated 2015-09-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.. Reason: Straps may separate from the foam pad..

Recalling firm: Covidien LLC
Classification: Class II
Status: Terminated
Initiated: 2014-05-08
Terminated: 2015-09-04
Firm location: Mansfield, MA, United States

Product description

Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.

Reason for recall

Straps may separate from the foam pad.

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