Events

Rappel de Device Recall Fisherbrand

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 Fisher Scientific Co.

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
    67786
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1521-2014
  • Date de mise en oeuvre de l'événement
    2014-02-05
  • Date de publication de l'événement
    2014-04-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126325
  • 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
    Applicator, absorbent tipped, sterile - Product Code KXG
  • Cause
    A customer reported the presence of an organism in a lot of calcium alginate fiber tipped wood applicator swab.
  • Action
    Fisher Scientific sent an Urgent: Medical Device Recall/Return letter dated March 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTIONS TO BE TAKEN BY THE USER OR DISTRIBUTOR: Fisher Scientific requests that you discontinue use and distribution of all products referenced above. We also request that you return all product (opened and unopened) as soon as possible. A credit will be issued for returned product. User: Fisher Scientific requests that you complete the Acknowledgment Form enclosed with this letter, even if you do not have the above mentioned product(s) in your inventory, within three (3) working days. Distributor: Our records indicate that you may have purchased one or more of the above products for re-sale to your customers. You should complete the attached Acknowledgment Form for inventory you have received and/or which is still in stock. Fisher Scientific requests that you complete and return the Acknowledgment Form enclosed with this letter, even if you do not have the above mentioned catalog numbers in your inventory, within three (3) working days. In addition, please contact your affected customer base to advise them of the expanded recall, by providing them with a copy of this letter. You should insert your contact information, email and fax numbers in the Acknowledgment Form and request that your customer return the Acknowledgment Form to you, and you notify us of the information conveyed in such Acknowledgment Form(s). ACTION BY FISHER SCIENTIFIC: Fisher Scientific has no inventory of the affected products as it was discontinued in May 2013. However, we do have alternative products that we can recommend as replacements. Please contact customer service for information on product alternatives. We appreciate your immediate attention to this expanded voluntary recall. By returning the attached Acknowledgment Form you wil

Device

Device Recall Fisherbrand
  • Modèle / numéro de série
    all lots of article nos. 14-959-77, 14-959-78, 14-959-79, 14-959-81, 14-959-82, lots 60151, 61513, 61933, 62768, 63055, 60752, 61324, 62195, 63224, 60752, 62195, 61866, 62546, 8710, with expiration dates August 2014 through October 2015
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack || Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack || Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Wood Applicator Swab, all lots, 100 and 200 per pack || culture collection and industrial surfaces
  • Manufacturer
    Fisher Scientific Co

Manufacturer

Fisher Scientific Co
  • Adresse du fabricant
    Fisher Scientific Co, 300 Industry Dr, Pittsburgh PA 15275-1001
  • Société-mère du fabricant (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA