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Class 2 Device Recall Prime Care, Prime Plus |
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Date Initiated by Firm |
August 11, 2014 |
Date Posted |
September 09, 2014 |
Recall Status1 |
Terminated 3 on July 19, 2017 |
Recall Number |
Z-2596-2014 |
Recall Event ID |
68805 |
Product Classification |
Cover, mattress (medical purposes) - Product Code FMW
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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. |
Code Information |
Lot numbers: 031512, 032912, 041712,041812, 060412,061312, 061412, 071312, 080912, 032713, 053013, and 053113. |
Recalling Firm/ Manufacturer |
Primus Medical LLC 8401 Southern Blvd Boardman OH 44512-6709
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For Additional Information Contact |
Ms. Layla Morris 330-965-9681 Ext. 107
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Manufacturer Reason for Recall |
The firm found that the top cover of the mattresses were delaminating.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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