Z-2596-2014Class II

Prime Care Transcend Mattress, Prime Care Transcend Perimeter Mattress, Prime Care Transcend Advanced...

Name: Z-2596-2014 Prime Care Transcend Mattress, Prime Care Transcend Perimeter Mattress, Prime Care Transcend Advanced...
Creator: Primus Medical LLC
Published: 2014-08-11
License: https://open.fda.gov/license/

Primus Medical LLC / initiated 2014-08-11 / Terminated / root cause: design

FDA source

Primus Medical LLC began a recall of Prime Care Transcend Mattress, Prime Care Transcend Perimeter Mattress, Prime Care Transcend Advanced Mattress, Prime Care Transcend Advanced Perimeter... on 2014-08-11. FDA classified it as Class II and gives the reason as "The firm found that the top cover of the mattresses were delaminating". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2596-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-11
Posted: 2014-09-09
Terminated: 2017-07-19
Recalling firm: Primus Medical LLC
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.
Product code: FMW Cover, Mattress (Medical Purposes)
Reason for recall: The firm found that the top cover of the mattresses were delaminating.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: Lot numbers: 031512, 032912, 041712,041812, 060412,061312, 061412, 071312, 080912, 032713, 053013, and 053113.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2596-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2596-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-09

Product code FMW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)