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U.S. Department of Health and Human Services

Class 2 Device Recall 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter,

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  Class 2 Device Recall 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, see related information
Date Initiated by Firm July 31, 2017
Create Date August 07, 2018
Recall Status1 Terminated 3 on March 12, 2019
Recall Number Z-2611-2018
Recall Event ID 80427
510(K)Number K964435  K983559  
Product Classification Stopcock, i.V. Set - Product Code FMG
Product 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, 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 061-C6028, Lot Number 3414382
Recalling Firm/
ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
For Additional Information Contact
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 2
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.