Events

Rappel de Wrist restraint, wrist cuff

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 J T Posey Company.

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
    63622
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1071-2013
  • Date de mise en oeuvre de l'événement
    2012-10-31
  • Date de publication de l'événement
    2013-04-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-07-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114375
  • 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
    protective restraint - Product Code FMQ
  • Cause
    The firm voluntarily recalled biothane restraint cuffs, catalog no. 2900, that did not meet the required specifications for tensile strength. failure of these rivets could allow the cuff to become disconnected from the connecting strap and allow patients to regain free use of the limb.
  • Action
    J. T. Posey sent an Medical Device Recall (Removal) letter to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed the customer that Posey Company is voluntarily recalling all units of Posey BiothaneQD Cuffs, Catalog Number 2900. All lots of this product are being recalled. Reason for recall was listed:"Posey has identified rivets on the Biothane~ Restraint Cuffs, Catalog No. 2900, that did not meet the required specifications for tensile strength. Failure of these rivets could allow the cuff to become disconnected from the connecting strap and allow patients to regain free use of the limb. No patient injuries or deaths have reported." Please immediately discontinue further distribution or use of Posey Biothane~ Cuffs, Catalog Number 2900. Please Complete and return the Acknowledgement and Receipt Form to Posey within 7 days using the provided self-addressed, stamped envelope, by fax to 626-443-5418 or via e-mail to RegulatoryAffairs@Posey.com. Return this form even if you do not have any devices in your facility. Please return directly to Posey ill! units you have of Biothane~ Cuffs, Catalog Number 2900, using the enclosed pre-paid shipping label containing an RMA number. Posey will provide replacement product or credit upon receipt of the product. If you have any further questions please call (626) 443-3143.

Device

Wrist restraint, wrist cuff
  • Modèle / numéro de série
    The model/catalog number for the device is 2900. All lots are being recalled.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Posey Biothane Restraint Cuffs, Catalog Number 2900. || The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.
  • Manufacturer
    J T Posey Company

Manufacturer

J T Posey Company
  • Adresse du fabricant
    J T Posey Company, 5635 Peck Rd, Arcadia CA 91006-5851
  • Source
    USFDA