EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
FDA Recall Z-0578-2018 · Posted 2018-01-09
Recalling FirmLITTLE RAPIDS CORPORATION
Recall StatusTerminated
Product CodeKME
Date Initiated2017-12-27
Date Terminated2018-07-30
Product Quantity153 cases, 30 units in each case
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.
Firm Action
The firm initiated their recall by email on 12/27/2017 to their direct consignees. The consignees were directed to report back with the number of products on hand for return and to notify their customers of the recall.
Root Cause
Device Design
Distribution Pattern
TX, CT, TN, MO, WI, FL, SD, MS, CA, MS
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.