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Recall Observatory FDA recall evidence

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

May 08, 2014

Class II

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

    reason.no_named_rule · v1.0.0

    Straps may separate from the foam pad.