EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 4703...
FDA Recall #Z-0578-2018 — Class II — December 27, 2017
Product Description
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
Reason for Recall
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.
Recalling Firm
LITTLE RAPIDS CORPORATION — Green Bay, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
153 cases, 30 units in each case
Distribution
TX, CT, TN, MO, WI, FL, SD, MS, CA, MS
Code Information
Lot codes: 17871, 17971, 18071, and 18971
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated