FDAFDA · Food and drugs·Recall number Z-2596-2014
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 Numbers: TCM3576, 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.
Published September 17, 2014 · Recall initiated: August 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm found that the top cover of the mattresses were delaminating.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Primus Medical LLC
- Distributor
- Worldwide Distribution -- USA, including the states of TX, OH, PA, KS, FL, NV, IL, WA, MN, NJ, NC, UT, NY, CA, MD, CO. NE VA, and AZ; and, the country of Canada.
- Lot
- Lot numbers: 031512, 032912, 041712,041812, 060412,061312, 061412, 071312, 080912, 032713, 053013, and 053113.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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