Device 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.
Z-1997-2014
Product summary
- Firm
- Covidien LLC
- Event
- Event 68243
- Status
- Terminated
- Classification
- Class II
- Quantity
- 264 devices
- Official record key
device-enforcement:Z-1997-2014
Official wording
Reason: Straps may separate from the foam pad.
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.
Distribution pattern: 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
Derived failure modes
-
Unknown
Straps may separate from the foam pad.