Events

Recall of Wrist restraint, wrist cuff

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by J T Posey Company.

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
    63622
  • Event Risk Class
    Class 2
  • Event Number
    Z-1071-2013
  • Event Initiated Date
    2012-10-31
  • Event Date Posted
    2013-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114375
  • 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
    protective restraint - Product Code FMQ
  • Reason
    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
  • Model / Serial
    The model/catalog number for the device is 2900. All lots are being recalled.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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
  • Manufacturer Address
    J T Posey Company, 5635 Peck Rd, Arcadia CA 91006-5851
  • Source
    USFDA