Events

Recall of Device Recall IV sets with stopcock

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ICU Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78191
  • Event Risk Class
    Class 2
  • Event Number
    Z-0106-2018
  • Event Initiated Date
    2017-08-31
  • Event Date Posted
    2017-11-17
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158863
  • Notes / Alerts
    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.
  • Extra notes in the data
    Stopcock, i.V. Set - Product Code FMG
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution and Internationally to TH.
  • Product Description
    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.
  • Manufacturer Address
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • Manufacturer Parent Company (2017)
    ICU Medical, Inc.
  • Source
    USFDA