Recall record at a glance
| Official record | Z-0578-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | LITTLE RAPIDS CORPORATION |
| Report date | Feb 21, 2018 |
| Recall initiation date | Dec 27, 2017 |
| Quantity | 153 cases, 30 units in each case |
| Location | Green Bay, WI, United States |
Official product description
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
Why the product was recalled
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 information
TX, CT, TN, MO, WI, FL, SD, MS, CA, MS
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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