Device product
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
Z-0578-2018
Product summary
- Event
- Event 78899
- Status
- Terminated
- Classification
- Class II
- Quantity
- 153 cases, 30 units in each case
- Official record key
device-enforcement:Z-0578-2018
Official wording
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.
Code information: Lot codes: 17871, 17971, 18071, and 18971
Distribution pattern: TX, CT, TN, MO, WI, FL, SD, MS, CA, MS
Derived failure modes
-
Unknown
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.