Events

Rappel de Device Recall MediChoice DualRelease Folding Walker

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Owens & Minor Distribution, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    68780
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0416-2015
  • Date de mise en oeuvre de l'événement
    2014-06-25
  • Date de publication de l'événement
    2014-11-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128647
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Walker, mechanical - Product Code ITJ
  • Cause
    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
  • Modèle / numéro de série
    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;
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    MediChoice Dual-Release Folding Walker with 5" wheel
  • Manufacturer
    Owens & Minor Distribution, Inc.

Manufacturer

Owens & Minor Distribution, Inc.
  • Adresse du fabricant
    Owens & Minor Distribution, Inc., 9120 Lockwood Blvd, Mechanicsville VA 23116-2015
  • Société-mère du fabricant (2017)
    Owens & Minor Distribution, Inc.
  • Source
    USFDA