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Class 2 Device Recall Devon Supine, Lithotomy and Trendelenburg Positioning Kit |
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Date Initiated by Firm |
May 08, 2014 |
Date Posted |
July 07, 2014 |
Recall Status1 |
Terminated 3 on September 04, 2015 |
Recall Number |
Z-1997-2014 |
Recall Event ID |
68243 |
Product Classification |
Support, patient position - Product Code CCX
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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. |
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. |
Recalling Firm/ Manufacturer |
Covidien LLC 15 Hampshire Street Mansfield MA 02048-1113
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For Additional Information Contact |
800-962-9888 Ext. 8
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Manufacturer Reason for Recall |
Straps may separate from the foam pad.
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FDA Determined Cause 2 |
Process control |
Action |
Covidien 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 Commerce |
264 devices |
Distribution |
US 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 Cycle |
TPLC Device Report
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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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