Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0568-2010

Paramed Polypropylene evacuation sled for non-ambulatory patients. Hand-carried stretcher. Product 11-778-01

Paramed Systems / initiated 2008-10-29 / Terminated

Paramed Systems began a recall of Paramed Polypropylene evacuation sled for non-ambulatory patients. Hand-carried stretcher. Product 11-778-01 on . The reason FDA records is "Possible partial board disassembly due to inadequate webbing attachment". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0568-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Paramed Systems
Product
Paramed Polypropylene evacuation sled for non-ambulatory patients. Hand-carried stretcher. Product 11-778-01.
Product code
FPP Stretcher, Hand-Carried
Reason for recall
Possible partial board disassembly due to inadequate webbing attachment.
FDA root cause
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.
Product codes and lots
Lot number 08/219/B.