Events

Rappel de Device Recall 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave Clear, NanoClave TConnector, Clamp, Rotating Lue

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
    79077
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1342-2018
  • Date de mise en oeuvre de l'événement
    2018-02-05
  • 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=161285
  • 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
    The infusion sets were manufactured with an incorrect spin collar.
  • Action
    The firm, ICU Medical Inc., sent an "URGENT: Medical Device Recall Notification" letter dated 2/5/2018 to its customers via UPS on 2/5/2018 in the U.S. The letter described the product, problem and actions to be taken. The customers were instructed to: inspect your inventory for specific product and lot numbers; quarantine all affected devices; complete and return the Recall Response Form as applicable (even if you have no affected devices) via Fax to: 1-866-899-7474 or email to: ICUMedical2805@stericycle.com; if you have distributed the product further, notify your accounts that received the product and ask them to contact Stericycle at 1-866-629-6182 (M-F, 8am-5pm ET) to receive a Response Form. Return affected product to Stericycle using labels provided, if you have not received a return label or reply form or require additional assistance, please contact Stericycle at 1-866-629-6182 (M-F, 8am-5pm) the return labels are for single use only. For additional labels visit http://expertezlabel.com. For further inquiries, please contact ICU Medical Inc. for Global Complaint Management at ProductComplaintsPP@icumed.com or ICU Customer Service at 1-866-829-9025, option 2 (M-F, 8:30am-4pm PT).

Device

Device Recall 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave Clear, NanoClave TConnector, Clam...
  • Modèle / numéro de série
    Lot numbers 3474877, UDI (01) 0 0887709 074578 (30) 500 (10)3474877; and Lot number 3481246, UDI  (01) 0 0887709 074578 (30) 500 (10) 3481246.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.
  • Description du dispositif
    6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San Clemente, CA. || The 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