FDA Device recall Z-0578-2018
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3 by Little Rapids, citing 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 trans….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0578-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-27 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Little Rapids |
| Distribution | CA, CT, FL, MO, MS, SD, TN, TX, WI |
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.
Identifiers
| upc | 10747036729303 |
|---|---|
| code_info | Lot codes: 17871, 17971, 18071, and 18971 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0578-2018%22
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