Events

Recall of Device Recall Posey

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
    49498
  • Event Risk Class
    Class 2
  • Event Number
    Z-0286-2009
  • Event Initiated Date
    2008-07-25
  • Event Date Posted
    2008-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73634
  • 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
    restraint - Product Code FMQ
  • Reason
    Failure to restrain: this recall was initiated after a complaint was received by the firm regarding a posey 2217sl unit indicating that a patient was able to pull the rivet or washer through the synthetic leather allowing the patient to have freedom of arm movement. a second complaint was received indicating that a patient was able to tear the strap at the adjustment notch on a posey 221 7sl unit.
  • Action
    On July 29, 2008 Posey sent a Recall Letter to all affected customers. The recall letters were sent by certified mail with return receipt signature. The recall letter instructed the customers not to distribute or use the affected products. Any existing inventory subject to this recall was requested to be returned to Posey Company. Also, if they were a distributor, they were asked to please additionally forward a copy of the recall notice and reply form to each of their customers to whom you have further distributed the subject product. A Recall Fax Back form was provided with the recall letter for the affected facilities to fax back to inform Posey of their existing inventory. An RMA number was issured to each facility and a return UPS label was provided for any product that will be returned to Posey. Additionally, the sales representatives for each of the customers will be contacted by Posey Customer Service.

Device

Device Recall Posey
  • Model / Serial
    Catalog Numbers: 2217SL and 2217B ; Note: All 22l7SL and 2217B units are affected by this recall.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, USA, Australia, Canada, France & The Netherlands.
  • Product Description
    Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B
  • Manufacturer
    J T Posey Company

Manufacturer

J T Posey Company
  • Manufacturer Address
    J T Posey Company, 5635 Peck Rd, Arcadia CA 91006
  • Manufacturer Parent Company (2017)
    Tidi Products Llc
  • Source
    USFDA