Events

Rappel de Device Recall Conforming Stretch Gauze Bandages, Sterile

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 Amd-Ritmed, 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
    73696
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2213-2016
  • Date de mise en oeuvre de l'événement
    2016-03-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-07-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144770
  • 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
    Bandage, elastic - Product Code FQM
  • Cause
    The product lot did not meet sterility requirements based on fda sampling and analysis.
  • Action
    The firm, AMD-Ritmed, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 3/30/2016 and Medical Device Recall Response Form to the US distributors/customers via e-mail. The letter described the product, problem and actions to be taken. The customers were instructed to examine your stock to determine if you have any; immediately discontinue distributing product; promptly return product via parcel post to Tonawanda/Buffalo warehouse, ATTENTION: RETURNED GOODS, AMD-Ritmed Inc., 295 Firetower Drive, Tonawanda, NY 14150; if you have further distributed the product, immediately contact your accounts, advise them of the recall situation and have them return their outstanding stock, and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE-Acknowledgment & Receipt Form via email to : AMDCUSTOMERSERVICE@AMDRITMED.COM or fax to: 1-866-871-3455, ATTN: AMD-Ritmed Customer Service. If you have any questions, please contact us at (1-800-445-0340) or at AMD Customer Service AMDCustomerService@amdritmed.com.

Device

Device Recall Conforming Stretch Gauze Bandages, Sterile
  • Modèle / numéro de série
    Lot 64155, Expiration Date 2017-06
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution in states of: NY, CA, and TN.
  • Description du dispositif
    AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case. || Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.
  • Manufacturer
    Amd-Ritmed, Inc.

Manufacturer

Amd-Ritmed, Inc.
  • Adresse du fabricant
    Amd-Ritmed, Inc., 295 Fire Tower Dr, Tonawanda NY 14150-5833
  • Source
    USFDA