Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended
FDA device recall Z-1997-2014 · posted 2014-07-07 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- Straps may separate from the foam pad.
- Action taken
- 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
- Status
- Terminated
- Product code
- CCX
- Quantity affected
- 264 devices
- 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
- Date initiated
- 2014-05-08
- Date posted
- 2014-07-07
- Date terminated
- 2015-09-04
- Location
- Mansfield, MA
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