Recall Z-2596-2014 ยท FMW Cover, Mattress (Medical Purposes)
Primus Medical LLC
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, TACM3
| Date | Sep 9, 2014 (initiated Aug 11, 2014) |
| Status | Terminated |
| Reason | The firm found that the top cover of the mattresses were delaminating. |
| Root cause | Component design/selection |
| Action | The firm sent out Urgent: Voluntary Field Correction/Removal letters, dated August 11, 2014, to all consignees with instructions for correcting the issue. Customers were to immediately examine their inventory and quarantine any affected product. Customers are to complete and return the response form provided. Questions can be directed to 1-877-638-2776. |
| Quantity | 1,557 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.