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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.

FDA Recall Z-1997-2014 · Posted 2014-07-07

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeCCX
Date Initiated2014-05-08
Date Terminated2015-09-04
Product Quantity264 devices

Reason for Recall

Straps may separate from the foam pad.

Firm 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.

Root Cause

Process control

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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