Events

Rappel de Device Recall Anchor Tissue Retrieval System TRS100SB

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 Anchor Products Company, 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
    57432
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1590-2011
  • Date de mise en oeuvre de l'événement
    2010-12-09
  • Date de publication de l'événement
    2011-03-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96202
  • 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
    laparoscope, general & plastic surgery - Product Code GCJ
  • Cause
    The metal component within the unit can break and cause a malfunction. use of the device may represent a potential health hazard if the metal component is not removed after breakage.
  • Action
    The firm, Anchor, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated December 8, 2010 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any remaining units to their distributor for replacement; and complete and return the attached ANCHOR RECALL RETURN RESPONSE FORM via fax to (314) 961-4535 or mail to: Progressive Medical, Inc., Attn: Marketing Manager, 11085 Gravois Industrial Court, St. Louis, MO 63128, even if they have no inventory. A representative of Anchor Products then visited each of the direct accounts to help them implement their subrecall of the devices from their customers. For additional information please contact: Vice President, Anchor Products Company at 1-800-543-9124 or 1-630-543-9124; and the distributor at 1-800-969-6331 or 1-314-961-4535.

Device

Device Recall Anchor Tissue Retrieval System TRS100SB
  • Modèle / numéro de série
    Code TRS100SB, lots P05N, P07N, P11N, P13N, P19N, P20N, P23N, P25N, P29N, P30N, P31N, P34N, P37N, P41N, P42N, P43N, P44N, P46N, P47N, P48N, P49N, P51N, P52N, P53N, P55N, P56N, P57N, P58N, P60N, P61N, P66N, P68N, P69N, P71N, P75N, P78N, P85N, P90N, P94N, P94N, P96N, P98N, P99N, Q02N, Q04N, Q05N, Q06N, Q09N, Q11N, Q12N, Q13N, Q14N, Q17N, Q20N, Q23N, Q24N, Q30N, Q31N, Q36N, Q38N, Q41N, Q49N, Q50N and Q65N
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including state of: Missouri; and countries including: Australia, Belgium, Canada, France, Greece, Ireland, Japan, Spain and the United Kingdom.
  • Description du dispositif
    Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 10 mm, 225 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS100SB || The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery.
  • Manufacturer
    Anchor Products Company, Inc.

Manufacturer

Anchor Products Company, Inc.
  • Adresse du fabricant
    Anchor Products Company, Inc., 52 W Official Rd, Addison IL 60101-4519
  • Société-mère du fabricant (2017)
    Anchor Products Company
  • Source
    USFDA