Recall Z-2596-2014— Primus Medical LLC

Name: FDA recall Z-2596-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-11

Class II · Terminated

Class II FDA medical device recall by Primus Medical LLC, initiated 2014-08-11, terminated 2017-07-19. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: The firm found that the top cover of the mattresses were delaminating..

Recalling firm: Primus Medical LLC
Classification: Class II
Status: Terminated
Initiated: 2014-08-11
Terminated: 2017-07-19
Firm location: Boardman, OH, United States

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.