Events

Rappel de Posey Connecting Straps & Belts/Locking Cuffs.

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
    50134
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0934-2009
  • Date de mise en oeuvre de l'événement
    2008-09-08
  • Date de publication de l'événement
    2009-02-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74796
  • 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
    Restraint, protective - Product Code FMQ
  • Cause
    The recall was initiated after an investigation conducted by the posey company determined that a patient may be able to catch the belt on a stationary object (wall, pipe, etc.) and use their body force to tear or break the strap, creating freedom of arm movement. in some patient populations, such freedom of movement could pose an unwanted hazard of serious injury to a patient or caregiver.
  • Action
    An "Urgent Medical Device Recall (Correction)" letter dated August 15, 2008 was mailed via US Postal Service to affected customers. The letter described the issue, instructed customers to secure a replacement label with the correct application technique over the picture in the 2008 Posey Catalog and provided a corrected Posey Locking Cuffs Instruction Sheet (19273). The Posey Company also provided updated literature for the Posey Locking and Non-Locking Connecting Straps 19270 and 19254. The Posey Company asked customers to complete and return the "Reply Fax-Back Acknowledgment" Form via fax (626-443-5418) or e-mail (vcimmarusti@posey.com) within 7 days. Contact your Sales Representative with any questions or concerns.

Device

Posey Connecting Straps & Belts/Locking Cuffs.
  • Modèle / numéro de série
    Catalog Numbers: 2320, 2330, 2346, 2350, 2351, 2355, 2360, 2208, 2209, 2210, 2211, 2212 and 2213.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Australia, Belgium, Canada, France, Germany, Ireland, Italy, Korea, Lithuania and Netherlands.
  • Description du dispositif
    Posey Connecting Straps & Belts/Locking Cuffs. || The device is used to limit the wearer's movement by securing cuffs to a connecting strap or belt.
  • Manufacturer
    J T Posey Company

Manufacturer

J T Posey Company
  • Adresse du fabricant
    J T Posey Company, 5635 Peck Rd, Arcadia CA 91006
  • Société-mère du fabricant (2017)
    Tidi Products Llc
  • Source
    USFDA