Recall Z-0578-2018 ยท KME Bedding, Disposable, Medical
LITTLE RAPIDS CORPORATION
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
| Date | Jan 9, 2018 (initiated Dec 27, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 153 cases, 30 units in each case |
| Distribution | TX, CT, TN, MO, WI, FL, SD, MS, CA, MS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.