FDA-Device2018-02-21Class II
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
LITTLE RAPIDS CORPORATION
Hazard
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.
Sold states
TX, CT, TN, MO, WI, FL, SD, MS, CA, MS
Affected count
153 cases, 30 units in each case
Manufactured in
2273 Larsen Rd, Green Bay, WI, United States
Products
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0578-2018Don't want to check this manually?
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