FDA recall Z-0578-2018

Product

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

TX, CT, TN, MO, WI, FL, SD, MS, CA, MS

Key facts

Status

Terminated

Initiation date

2017-12-27

Report date

2018-02-21

Termination date

2018-07-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Green Bay, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0578-2018