Recall Z-0568-2010 ยท FPP Stretcher, Hand-Carried
Paramed Systems
Paramed Polypropylene evacuation sled for non-ambulatory patients. Hand-carried stretcher. Product 11-778-01.
| Date | Dec 28, 2009 (initiated Oct 29, 2008) |
| Status | Terminated |
| Reason | Possible partial board disassembly due to inadequate webbing attachment. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.