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Class 2 Device Recall ParaSlyde, Controlled descent device. |
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Date Initiated by Firm |
October 29, 2008 |
Date Posted |
December 28, 2009 |
Recall Status1 |
Terminated 3 on January 28, 2010 |
Recall Number |
Z-0568-2010 |
Recall Event ID |
53339 |
Product Classification |
Stretcher, hand-carried - Product Code FPP
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Product |
Paramed Polypropylene evacuation sled for non-ambulatory patients. Hand-carried stretcher. Product 11-778-01.
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Code Information |
Lot number 08/219/B. |
Recalling Firm/ Manufacturer |
Paramed Systems 8100 S 1300 W Ste D West Jordan UT 84088-8307
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For Additional Information Contact |
801-304-9299
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Manufacturer Reason for Recall |
Possible partial board disassembly due to inadequate webbing attachment.
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FDA Determined Cause 2 |
Process change control |
Action |
Customers were notified by letter and phone during 10/20/2008 and 10/29/2008 to schedule visits by Paramed to correct the devices. |
Quantity in Commerce |
722 Units |
Distribution |
Nationwide Distribution -- Including states of AZ, CA, FL, GA, IL, IN, KS, KY, MA, MI, MT, NY, PA, SC, TN and UT. |
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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