LITTLE RAPIDS CORPORATION recalls EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3

Recall date

December 27, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0578-2018

FDA classification

Class II

Brand / firm

LITTLE RAPIDS CORPORATION

Sold / distributed

TX, CT, TN, MO, WI, FL, SD, MS, CA, MS

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3