Z-0578-2018Class II

EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3

Name: Z-0578-2018 EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
Creator: Little Rapids Corporation
Published: 2017-12-27
License: https://open.fda.gov/license/

Little Rapids Corporation / initiated 2017-12-27 / Terminated / root cause: design

FDA source

LITTLE RAPIDS CORPORATION began a recall of EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3 on 2017-12-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0578-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-27
Posted: 2018-01-09
Terminated: 2018-07-30
Recalling firm: Little Rapids Corporation
Product: EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
Product code: KME Bedding, Disposable, Medical
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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm initiated their recall by email on 12/27/2017 to their direct consignees. The consignees were directed to report back with the number of products on hand for return and to notify their customers of the recall.
Quantity in commerce: 153 cases, 30 units in each case
Distribution: TX, CT, TN, MO, WI, FL, SD, MS, CA, MS
Product codes and lots: Lot codes: 17871, 17971, 18071, and 18971

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0578-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0578-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09

Product code KME

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)