Events

Recall of Device Recall SnugFit(R) Expandable Mattress Cover

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LITTLE RAPIDS CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78899
  • Event Risk Class
    Class 2
  • Event Number
    Z-0578-2018
  • Event Initiated Date
    2017-12-27
  • Event Date Posted
    2018-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160825
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bedding, disposable, medical - Product Code KME
  • 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.
  • 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.

Device

Device Recall SnugFit(R) Expandable Mattress Cover
  • Model / Serial
    Lot codes: 17871, 17971, 18071, and 18971
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    TX, CT, TN, MO, WI, FL, SD, MS, CA, MS
  • Product Description
    EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3
  • Manufacturer
    LITTLE RAPIDS CORPORATION

Manufacturer

LITTLE RAPIDS CORPORATION
  • Manufacturer Address
    LITTLE RAPIDS CORPORATION, 2273 Larsen Rd, Green Bay WI 54303-4809
  • Manufacturer Parent Company (2017)
    Little Rapids Corporation
  • Source
    USFDA