Recall Z-0578-2018— LITTLE RAPIDS CORPORATION
Class II · Terminated
Class II FDA medical device recall by LITTLE RAPIDS CORPORATION, initiated 2017-12-27, terminated 2018-07-30. FDA's recall record names no specific 510(k) clearance for this event. Product: EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3. 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..
- Recalling firm
- LITTLE RAPIDS CORPORATION
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-27
- Terminated
- 2018-07-30
- Firm location
- Green Bay, WI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.