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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-0568-2010
Recalling firm
Paramed Systems
Product
Paramed Polypropylene evacuation sled for non-ambulatory patients. Hand-carried stretcher. Product 11-778-01.
Status
Terminated
Initiated
2008-10-29
Posted
2009-12-28
Terminated
2010-01-28
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.
Lot, serial or model codes
Lot number 08/219/B.
510(k) numbers
not on file
PMA numbers
not on file
Product code
FPP
Firm FEI
3004828791
Firm city
West Jordan
Firm state
UT
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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