BEUDAMED
    FDA Recall Open, Classified

    Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.

    Recall: Z-1211-2023 · Initiated January 18, 2023

    Recall

    Recall Number
    Z-1211-2023
    Event Number
    91492
    Firm
    Linet Spol. S.r.o. Zelevcice 5 Zelevcice Czech Republic
    FEI Number
    3008058231
    Product Code
    FPO
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    January 18, 2023
    Posted
    March 4, 2023

    Description

    Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.

    Reason

    Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury.

    Action

    The firm issued "URGENT MEDICAL DEVICE CORRECTION" recall letters dated 1/17/2023 via email on 1/18/2023. The letter explains the issue that an audible clicking sound can be heard when the side rail is raised, but this sound does not indicate the side rail has locked into the raised position. The consignee is to take immediate action to notify caregivers using the Sprint 200 of this potential hazard and proper use for securing a side rail in the raised position. The consignee is informed that Linet will be adding additional safety warning labels located at each side rail latch (2 per side of stretcher), add additional safety warning labels to both side rails (1 per side of stretcher), and that additional training material and an updated copy of the Sprint 200 Emergency Stretcher Instructions for Use and Technical Description manual is available using the QR code in the letter or by following a link to access the materials. The firm's service department will be contacting the consignees to schedule an appointment to perform the corrections. Photos of the additional warning labels are included in the letter. Please contact LINET service department at 877-815-9897 with immediate questions or concerns.

    Distribution

    US Distribution was made to AL, CA, FL, IA, KY, LA, MN, NV, NC, OK, TX, VA, WA, and WV. There was no government/military distribution. Foreign distribution was made to Australia, Bahrain, Belgium, Germany, Great Britain, Italy, Netherland, Singapore, South Africa, Switzerland, and United Emirates Canada.

    Quantity

    335 stretchers (310 US, 25 OUS)