FDAFDA · Food and drugs·Recall number Z-0578-2018
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
Published February 21, 2018 · Recall initiated: December 27, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- LITTLE RAPIDS CORPORATION
- Distributor
- TX, CT, TN, MO, WI, FL, SD, MS, CA, MS
- Lot
- Lot codes: 17871, 17971, 18071, and 18971
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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