FDAClass IIFebruary 21, 2018

EMS products from Graham Medical recall

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

Why was EMS products from Graham Medical 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot codes: 17871, 17971, 18071, and 18971

Product
EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
Recalling firm
LITTLE RAPIDS CORPORATION
Quantity
153 cases, 30 units in each case
Distribution
TX, CT, TN, MO, WI, FL, SD, MS, CA, MS
Recall date
February 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls