Events

Rappel de Device Recall IV sets with stopcock

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 ICU Medical, 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
    78191
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0106-2018
  • Date de mise en oeuvre de l'événement
    2017-08-31
  • Date de publication de l'événement
    2017-11-17
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158863
  • 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
    Stopcock, i.V. Set - Product Code FMG
  • Cause
    Icu medical has identified certain stopcocks that are incorporated in iv sets may contain a metallic burr.
  • Action
    ICU Medical, Inc. sent an Urgent Medical Device Recall Notification dated August 31, 2017. Customers will be instructed to quarantine any devices and return to ICU. Recipients will be instructed to continue the recall through to the end user of the device. Please call Customer Service, Monday through Friday between the hours of 7 am through 4:30pm CST  @ 877-946-7747 and select option 9, or e-mail the following address: Productreturns@icumed.com

Device

Device Recall IV sets with stopcock
  • Modèle / numéro de série
    Lot Number 3458321, 3462452, 3465813, 3442569, 3446005, 3450752, 3465816, 3456237, 3486340, 3451451, 3447667, 3447427, 3471329, 3462010, 3447673, 3470589, 3466170, 3462856, 77-979-Y1, 76-113-Y1, 76-114-Y1, 77-981-Y1, 77-259-Y1, 77-023-HE, 77-481-Y1, 78-637-HE, 77-034-HE, 77-222-Y1, 77-341-HE, 77-354-Y1, 77-613-Y1, 77-033-HE, 76-101-Y1, 77-305-HE, 76-059-Y1, 77-149-Y1, 78-466-HE, 79-571-JW, 77-203-Y1
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution and Internationally to TH.
  • Description du dispositif
    SURPLUG MICRO CONNECTOR Item No. 066-C3352; || 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B30167; || 32" Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B30243; || 10" Ext Set w/Remv 3-Way Stopcock w/MicroClave, Clamp, Rotating Luer Item No. B33084; || 3-Way High Flow Stopcock w/Rotating Luer Item No. B4020; || 38" Non-DEHP Smallbore Ext Set w/2 T-Connectors/Inj Sites, Remv 3-Way Stopcock, 2 Clamps, Luer Slip Item No. B4054; || 300" Ext Set w/Remv 3-Way Stopcock, Check Valve, Clamp, Rotating Luer Item No. B4121; || 3 Gang 3-Way Stopcocks w/Rotating Luer Item No. B4154; || 33" Ext Set w/Remv 3-Way Stopcock, Luer Lock Item No. B4171; || 35" (89 cm) Transfer Set w/3-Way Stopcock, Clamp, Rotating Luer Item No. B4181; || 113" 15 Drop Primary Set w/2 MicroClave, Remv 3 Gang Manifold w/2 1o2, 3 Way Stopcock, Rotating Luer, 1 Ext Item No. B5153; || 131" (333 cm) Appx 17.2 mL, 20 Drop Admin Set w/4 Pre-slit Ports, MicroClave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. B9900-510; || 101" 15 Drop Primary Set w/2 MicroClave, Rotating Luer, 1 Smallbore T-Connector Ext w/Remv 3-Way Stopcock Item No. B99262; || 140" (356 cm) Appx 18.0 ml, 15 Drop Primary Set w/3 Clave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z0060; || 140" (356 cm) Appx 17.9 mL, 15 Drop Primary Set w/BCV-Clave, 2 Clave, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z0143; || 40" Ext Set w/Removable 2 Gang 3-Way Stopcocks, Pre-Pierced Port, Clamp, Rotating Luer Item No. Z1746; || 136" (345 cm) Appx 18.0 ml, 10 Drop Primary Set w/3 Inj Sites, Remv 3-Way Stopcock, Rotating Luer, 1 Ext Item No. Z2003; || 137" (348cm) Appx 17.5ml, 15 Drop Primary Set w/BCV-Clave, Clave, Remv 2 Gang 3-Way Stopcocks, Rotating Luer, 2 Ext Item No. Z2367; || 48" Ext Set w/Remv 3-Way Stopcock, 2 Clave, MicroClave T-Conn, 3 Clamps, Rotating Luer, 1 Ext, Smallbore Item No. Z2722; || 126" 15 Drop Primary Set w/3 MicroClave, Remv 2 Gang 3-Way Stopcocks, Rotating Luer, 1 Ext Item No. Z2760; || 114" (290 cm) 60 Drop 150ml Burette Set (w/MicroClave Shut Off, Filter), 3 Pre-Slit Ports, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Smallbore Ext Set w/Clave Item No. Z3284; || 3-Way Stopcock w/Rotating Luer Item No. Z3295; || 111" (282 cm) Appx 14.0 ml, 15 Drop Primary Set w/BCV-Clave, Clave, Remv 3-Way Stopcock, Rotating Luer w/Filter Cap, 1 Ext Item No. Z3705 || The ICU intravascular administration set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
  • Manufacturer
    ICU Medical, Inc.

Manufacturer

ICU Medical, Inc.
  • Adresse du fabricant
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • Société-mère du fabricant (2017)
    ICU Medical, Inc.
  • Source
    USFDA