Events

Rappel de Device Recall Heparin I.V. Flush Syringe 10 units/mL

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 Medefil Incorporated.

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
    57096
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0600-2011
  • Date de mise en oeuvre de l'événement
    2010-11-01
  • Date de publication de l'événement
    2010-12-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95387
  • 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
    Heparin Vascular Access Flush - Product Code NZW
  • Cause
    The heparin lock flush solution was manufactured with contaminated heparin sodium usp active pharmaceutical ingredient (api).
  • Action
    Medefil faxed/emailed the direct accounts on 11/1/10, and sent the accounts a hard copy of the Urgent Product Recall letter, dated 11/1/2010, on 11/2/10. The accounts were informed of Medefil's recall of 18 lots of Heparin I.V. Flush Syringes produced from the active pharmaceutical ingredient (API) Heparin Sodium, USP, lot 1035-0780, that has been recalled by the manufacturer, Scientific Protein Laboratories, due to the presence of a contaminant, Oversulfated Chondroitin Sulfate. The accounts were instructed to stop use of the 18 lots of Heparin I.V. Flush Syringes immediately, place them under quarantine, and contact Medefil to arrange for the product to be returned. The accounts were requested to complete and return to Medefil the enclosed response form, indicating the quantity on hand of each recalled lot. Any questions were directed to Pradeep Aggarwal, President at 630-682-4600.

Device

Device Recall Heparin I.V. Flush Syringe 10 units/mL
  • Modèle / numéro de série
    a) catalog # MIH-2221: Lot H10228, exp. date 04/12; b) catalog # MIH-2223: Lot H10262, exp. date 05/12; c) catalog # MIH-2235: Lot H10190, exp. date 03/12; Lot H10229, exp. date 04/12; Lot H10278, exp. date 06/12.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution --- including states of Arizona, California, Florida, Illinois, Ohio, Louisiana, Massachusetts, Michigan, Minnesota, New York, Texas, and Virginia.
  • Description du dispositif
    Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 10 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc. Glendale Heights, IL 60139. The pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-222-21, catalog # MIH-2221: 1 mL fill in 6 mL syringe; b) NDC# 64253-222-23, catalog # MIH-2223: 3 mL fill in 6 mL syringe; c) NDC# 64253-222-35, catalog # MIH-2235: 5 mL fill in 12 mL syringe
  • Manufacturer
    Medefil Incorporated

Manufacturer

Medefil Incorporated
  • Adresse du fabricant
    Medefil Incorporated, 250 Windy Point Dr, Glendale Heights IL 60139-3805
  • Société-mère du fabricant (2017)
    Medefil Inc.
  • Source
    USFDA