Events

Rappel de Device Recall Pulset Arterial Blood Gas (ABG) sampling kit.

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 Westmed 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
    63276
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0104-2013
  • Date de mise en oeuvre de l'événement
    2011-01-18
  • Date de publication de l'événement
    2012-10-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113398
  • 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
    Arterial blood sampling kit - Product Code CBT
  • Cause
    Westmed is recalling westmed abg convenience kits containing triad brand alcohol pads because triad is recalling triad brand alcohol pads due to potential contaminants.
  • Action
    Westmed sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 18, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were also given the TRIAD GROUP: "Urgent Drug Recall" and "Facts: Alcohol Recall" both dated January 3, 2011. Westmed customers were instructed to remove the TRIAD alcohol pad from the kit and dispose of the alcohol pad only. Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with questions were instructed to contact the firm at (520) 264-7987 x1233.

Device

Device Recall Pulset Arterial Blood Gas (ABG) sampling kit.
  • Modèle / numéro de série
    Lot Numbers: 38941, 39213, 40203, 41694, 42317, 42700, 43129, 43195, 43502, 44695, 45065, 45254, 45919, 46776, 47369, 4669149785.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, El Salvador, United Arab Emirates, Holland, Costa Rica and Lebanon.
  • Description du dispositif
    Pulset Arterial Blood Gas (ABG) sampling kit. || Full Kit, Pulset, 3 cc, 22 g x 1" A/B Needle, 25U Balanced Heparin, part number: 3372. || An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
  • Manufacturer
    Westmed Inc

Manufacturer

Westmed Inc
  • Adresse du fabricant
    Westmed Inc, 5580 S Nogales Hwy Ste 170, Tucson AZ 85706-3333
  • Société-mère du fabricant (2017)
    Westmed Holding Company
  • Source
    USFDA