Events

Rappel de Device Recall A2376 Extra Supplies 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 Heritage Labs International LLC.

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
    64848
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1131-2013
  • Date de mise en oeuvre de l'événement
    2013-02-06
  • Date de publication de l'événement
    2013-04-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117176
  • 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
    System, blood collection, vacuum-assisted, manual - Product Code KST
  • Cause
    The product has a lithium heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
  • Action
    The recalling firm contacted 25 of their 26 customers by phone on February 5, 2013, to notify them of the recall and sent a follow up memo on February 6, 2013, During the call, the firm reminded their customers how many recalled kits they recieved and instructed them to go through the kits and pull the recalled lots. The recalled kits are to be returned to the recalling firm and the firm sent a follow-up memo on February 6, 2013, with the shipping label their customers to place on the returning kit shipping box. This memo was sent to the customers by overnight Fed-ex mail and the ship label for the returned product was an overnight UPS label. On February 7, 2013, the final customer was notified by phone and instructed to return the recalled kits. For further questions please call (913) 764-1045.

Device

Device Recall A2376 Extra Supplies Kit
  • Modèle / numéro de série
    Lot A2376-12307, exp 2/28/2013 and Lot A2376-12272, exp 4/30/2013
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA.
  • Description du dispositif
    Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. || The kit is used by health care providers when treating patients.
  • Manufacturer
    Heritage Labs International LLC

Manufacturer

Heritage Labs International LLC
  • Adresse du fabricant
    Heritage Labs International LLC, 560 N Rogers Rd, Olathe KS 66062-1211
  • Source
    USFDA