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U.S. Department of Health and Human Services

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

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 Class 2 Device Recall 120" (305 cm) 10 Drop Primary Set w/2 MicroClavesee related information
Date Initiated by FirmJuly 31, 2017
Create DateAugust 07, 2018
Recall Status1 Terminated 3 on March 12, 2019
Recall NumberZ-2658-2018
Recall Event ID 80427
510(K)NumberK964435 K983559 
Product Classification Stopcock, i.V. Set - Product Code FMG
Product120" (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 2
Labeling mix-ups
ActionThe 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 Commerce160,016 units total
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = FMG
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