Z-0578-2018 Class II Terminated
FDA device recall Z-0578-2018 was initiated by LITTLE RAPIDS CORPORATION on December 27, 2017 and is designated Class II. 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. Ho… The recall status is terminated (terminated July 30, 2018). Affected quantity: 153 cases, 30 units in each case.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- December 27, 2017
- Termination Date
- July 30, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 153 cases, 30 units in each case
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.
Distribution Pattern
TX, CT, TN, MO, WI, FL, SD, MS, CA, MS
Code Information
Lot codes: 17871, 17971, 18071, and 18971