Class 2 Device Recall 120" (305 cm) 10 Drop Primary Set w/2 MicroClave

• Date Initiated by Firm: July 31, 2017
• Create Date: August 07, 2018
• Recall Status: Terminated on March 12, 2019
• Recall Number: Z-2658-2018
• Recall Event ID: 80427
• 510(K)Number: K964435 K983559
• Product Classification: Stopcock, i.V. Set - Product Code FMG
• Product: 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile; ; The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
• Code Information: Item Number Z4089, Lot Number 69-717-SJ, 70-260-SL, 73-197-HE, 74-725-JW
• Recalling Firm/ Manufacturer: ICU Medical, Inc.; 951 Calle Amanecer; San Clemente CA 92673-6212
• For Additional Information Contact: 949-366-2183
• Manufacturer Reason for Recall: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
• FDA Determined Cause: Labeling mix-ups
• Action: The firm, ICUmedical, notified their customers of the recall on about 07/31/2017 via"URGENT: Medical Device Recall Notification letter". Instructions included to inspect inventory on hand for affected devices, remove and return any affected devices, and complete and return the Recall Response Form to ICU Medical RecallCoordinator; email:.Recall@icumed.com; including labeling "Incorrect labeling" in subject or FAX: (801) 264-1755. Instructions also included to notify customers of the recall if devices were further distributed. Questions can be directed to ICU Customer Service Monday through Friday, 7 AM CST - 4:30 PM CT at 877-946-7747, option 9 or e-mail at ProductReturns@icumed.com
• Quantity in Commerce: 160,016 units total
• Distribution: Worldwide Distribution: US (nationwide) distribution to AL, AR, CA, CT, DE, FL, IA, IL, IN, KS, MA, MD, ME, MI, MO, NC, NJ, NY, OH, OR, PA, RI, TN, TX, UT, VA, WA, WV; and countries of:: Canada, Cyprus, Japan, Kuwait, MALAYSIA ,and South Africa.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FMG and Original Applicant = ICU MEDICAL, INC.