Prime Care Transcend Mattress, Prime Care Transcend Perimeter Mattress, Prime Care Transcend Advanced Mattress, Prime Ca
FDA device recall Z-2596-2014 · posted 2014-09-09 · Terminated
Recall details
- Recalling firm
- Primus Medical LLC
- Reason for recall
- The firm found that the top cover of the mattresses were delaminating.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- FMW
- Quantity affected
- 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.
- Date initiated
- 2014-08-11
- Date posted
- 2014-09-09
- Date terminated
- 2017-07-19
- Location
- Boardman, OH
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