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U.S. Department of Health and Human Services

Class 2 Device Recall Devon Supine, Lithotomy and Trendelenburg Positioning Kit

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 Class 2 Device Recall Devon Supine, Lithotomy and Trendelenburg Positioning Kitsee related information
Date Initiated by FirmMay 08, 2014
Date PostedJuly 07, 2014
Recall Status1 Terminated 3 on September 04, 2015
Recall NumberZ-1997-2014
Recall Event ID 68243
Product Classification Support, patient position - Product Code CCX
ProductDevon 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.
Code Information 14085, 14086, 14092, 14095, 14101, 14106  *The original recall submission listed 14084 and 14094, these were reported by Covidien in error on the original submission.
FEI Number 1282497
Recalling Firm/
Manufacturer		 Covidien LLC
15 Hampshire Street
Mansfield MA 02048-1113
For Additional Information Contact
800-962-9888 Ext. 8
Manufacturer Reason
for Recall		Straps may separate from the foam pad.
FDA Determined
Cause 2		Process control
ActionCovidien Sales Representatives notified customers in person by beginning May 8, 2014. The Sales Representative will provided a copy of the Recall letter (attachment 4), and collect any remaining product at the site. The notification and recovery of the product is expected to be complete no later than May 14, 2014.
Quantity in Commerce264 devices
DistributionUS Nationwide Distribution in the states of NJ, CA, TX, IL, MO, PA, OH, IN, MI, MN, FL, IN, DC, PA, VA, MS, ME, NV, AR, KY, NY, KS, SC
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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