Events

Recall of Device Recall MediChoice DualRelease Folding Walker

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Owens & Minor Distribution, Inc..

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
    68780
  • Event Risk Class
    Class 2
  • Event Number
    Z-0416-2015
  • Event Initiated Date
    2014-06-25
  • Event Date Posted
    2014-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128647
  • 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
    Walker, mechanical - Product Code ITJ
  • Reason
    Product wheels may be too loose, too tight, or fall off.
  • Action
    Customers were notified via letter and email by June 27, 2014. to take the following actions: 1. Designate a quarantine location in the DC for the recalled lots and serial numbers. 2. Label this area very clearly as "RECALLED PRODUCT IN QUARANTINE". 3. Clearly segregate the area to prevent the product from being moved or handled and to further designate that the product is in quarantine. 4. Record each case lot# or walker serial number if the product is out of the case on the recall inventory report. 5. Label each unit in the quarantine area with a label that clearly states RECALLED PRODUCT IN QUARANTINE. 6. Conduct a daily inventory verification check using to ensure the inventory still remains in quarantine. In addition, please forward a copy of this letter to hospital personnel in a position to notify patients who may have received and been discharged with a walker from the lots and serial numbers identified above. Hospital Customers: Contact your local DC Customer Service Representative who will assist in returning and replacing the recalled walker. Patients Who May Have Received a Recalled Walker from a Hospital: Contact Owens & Minor Mainstreet Customer Service at 1-800-818-6664 who will assist you in returning and replacing a walker.

Device

Device Recall MediChoice DualRelease Folding Walker
  • Model / Serial
    Item 1314077745. Lot#/Serial #s: 1304CA07A 1307000381-1307001520;  1306CA07A 1307001521-1307002184;   1307CA07A 1307002185-1307002888;   1309CA07A 1307002889-1307003292;   1310CA07A 1307003293-1307004044;   1311CA07A 1307004045-1307004752;  1312CA07A 1307004753-1307005236;
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of CA, CO, CT, GA, IL, MA, MD, ME, MI, NE, NH, NJ, NY, OH, OR, PA, SC, TX, UT, VA, VT, WA and WY.
  • Product Description
    MediChoice Dual-Release Folding Walker with 5" wheel
  • Manufacturer
    Owens & Minor Distribution, Inc.

Manufacturer

Owens & Minor Distribution, Inc.
  • Manufacturer Address
    Owens & Minor Distribution, Inc., 9120 Lockwood Blvd, Mechanicsville VA 23116-2015
  • Manufacturer Parent Company (2017)
    Owens & Minor Distribution, Inc.
  • Source
    USFDA