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U.S. Department of Health and Human Services

Class 2 Device Recall SnugFit(R) Expandable Mattress Cover

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  Class 2 Device Recall SnugFit(R) Expandable Mattress Cover see related information
Date Initiated by Firm December 27, 2017
Date Posted January 09, 2018
Recall Status1 Terminated 3 on July 30, 2018
Recall Number Z-0578-2018
Recall Event ID 78899
Product Classification Bedding, disposable, medical - Product Code KME
Product EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
Code Information Lot codes: 17871, 17971, 18071, and 18971
Recalling Firm/
2273 Larsen Rd
Green Bay WI 54303-4809
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.