Reported Sep 17, 2014 · Terminated

Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, Prime Care ¿ Transcend Advanced Mattress,…

Primus Medical LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Primus Medical LLC · 8401 Southern Blvd · Boardman, OH · 44512-6709

Is this the product you have?

  • Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, Prime Care ¿ Transcend Advanced Mattress, Prime Care ¿ Transcend Advanced Perimeter Mattress, Prime Plus ¿ Bariatric Mattress and Prime Plus ¿ Bariatric Perimeter Mattress, individual units packaged seperately
  • Model NumbersTCM3576, TCM3580, TCM3580P, TCM3584, TCM4280, TCM4280P, TCM4284, TACM3576, TACM3580, TACM3580P, TACM3584, PPBM396, PPBM426, PPBM426P, PPBM486, PPBM546, PPBM397, PPBM427, and PPBM487. Intended to protect inner foam layers of mattress from any fluids that may be on the mattress
Lot codes and dates
  • Lot numbers
    • 031512
    • 032912
    • 041712
    • 041812
    • 060412
    • 061312
    • 061412
    • 071312
    • 080912
    • 032713
    • 053013
    • and 053113
Amount recalled
1,557 units

Where it was sold

Why it was recalled

The firm found that the top cover of the mattresses were delaminating.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 19, 2017 · Data as of Sep 19, 5:28 PM UTC

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