Events

Recall of Device Recall 5" (13 cm) Smallbore Ext Set w/MicroClave, Clave TConnector, Clamp, Rotating Luer

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
    79077
  • Event Risk Class
    Class 2
  • Event Number
    Z-1346-2018
  • Event Initiated Date
    2018-02-05
  • 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=161289
  • 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
    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 5" (13 cm) Smallbore Ext Set w/MicroClave, Clave TConnector, Clamp, Rotating Luer
  • Model / Serial
    Lot number 3549002, UDI 01) 0 0887709 01857 0 (17) 221001 (30) 01 (10) 3549002.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.
  • Product Description
    5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, 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.
  • Manufacturer Address
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • Manufacturer Parent Company (2017)
    ICU Medical, Inc.
  • Source
    USFDA