Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0578-2018 — EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3

U.S. FDA — Device Enforcement · United States · 2017-12-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0578-2018
Date of alert
2017-12-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
LITTLE RAPIDS CORPORATION
Product category
device
Product type
Devices
Reported risk: The secondary supplier provided material was within specification but did not meet our design needs compared to the primary manufacturer. The product is designed for patient transfer, not lifting. However, we recognize that the product may be utilized outside of its intended design scope, and lifting may occur. Lifting could lead tearing of the equipment cover and the potential for patient falling through.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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