Events

Recall of Device Recall TransMotion Stretcher Chair

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Winco Mfg., LLC.

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
    74922
  • Event Risk Class
    Class 2
  • Event Number
    Z-0066-2017
  • Event Initiated Date
    2016-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148798
  • 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
    Stretcher, hand-carried - Product Code FPP
  • Reason
    Non-conforming component caused arms of tmm4 stretcher chair to no longer meet design specifications.
  • Action
    Customers were sent an Urgent: Medical Device Recall notification on 7/12/2016 for the specific models of the TransMotion (TMM) Stretcher chairs. The letter explained the reason for the recall and asked customers to take action. Customers are asked to follow the instruction in the Operator Manual for proper egress. Patients are not allowed to egress from the chair without assistance nor should they be left unattended. The chairs will be repaired on site; and, removal of the chair from service is not required with proper supervision and use. Customers are asked to complete the instructions for the acknowledgement form and return. The firm will contact the customers to arrange for repair. Questions regarding the field correction should be directed to the Customer Care department at 800-237-3377 or 352-854-2929 or e-mail QA-RA@wincomfg.com

Device

Device Recall TransMotion Stretcher Chair
  • Model / Serial
    All identified serial numbers.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including AR, CA, CO, CT, FL, GA, IL, KS, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, VA, WA, WI, and Puerto Rico; and the countries of Canada, Australia, Italy, Panama, Switzerland and Taiwan.
  • Product Description
    TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. || Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.
  • Manufacturer
    Winco Mfg., LLC

Manufacturer

Winco Mfg., LLC
  • Manufacturer Address
    Winco Mfg., LLC, 5516 SW 1st Ln, Ocala FL 34474-9307
  • Manufacturer Parent Company (2017)
    Winco Mfg. Llc
  • Source
    USFDA