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U.S. Department of Health and Human Services

Class 2 Device Recall ParaSlyde, Controlled descent device.

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 Class 2 Recall
ParaSlyde, Controlled descent device.
see related information
Date Posted December 28, 2009
Recall Status1 Terminated on January 28, 2010
Recall Number Z-0568-2010
Recall Event ID 53339
Product Classification Stretcher, Hand-Carried - Product Code FPP
Product Paramed Polypropylene evacuation sled for non-ambulatory patients. Hand-carried stretcher. Product 11-778-01.
Code Information Lot number 08/219/B.
Recalling Firm/
Manufacturer
Paramed Systems
8100 S 1300 W Ste D
West Jordan, Utah 84088-8307
Manufacturer Reason
for Recall
Possible partial board disassembly due to inadequate webbing attachment.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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