FDA Recall
Terminated
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.
Recall: Z-1997-2014
·
Initiated May 8, 2014
Recall
- Recall Number
- Z-1997-2014
- Event Number
- 68243
- Firm
- Covidien LLC
- FEI Number
- 1282497
- Product Code
- CCX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- May 8, 2014
- Posted
- July 7, 2014
- Terminated
- September 4, 2015
- Address
- 15 Hampshire Street, Mansfield, MA, 02048-1113
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
Straps may separate from the foam pad.
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.
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
Quantity
264 devices