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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
