—#127205

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.

FDA product code: CCX — Support, Patient Position
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: 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.

Why it was recalled

Straps may separate from the foam pad.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Covidien LLC
Address: 15 Hampshire Street, Mansfield, Massachusetts 02048-1113

Distribution

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

Timeline

Recall initiated: 2014-05-08
Posted by FDA: 2014-07-07
Terminated: 2015-09-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127205. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.