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U.S. Department of Health and Human Services

Class 2 Device Recall Bifuse Transfer Set w/Rotating Luer

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  Class 2 Device Recall Bifuse Transfer Set w/Rotating Luer see related information
Date Initiated by Firm August 20, 2018
Create Date October 04, 2018
Recall Status1 Completed
Recall Number Z-0069-2019
Recall Event ID 80946
510(K)Number K964435  
Product Classification Stopcock, i.V. Set - Product Code FMG
Product ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28

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).
Code Information lots: 85-540-SJ, 86-189-SL, 86-911-SJ
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
Manufacturer Reason
for Recall		 Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.
FDA Determined
Cause 2		 Device Design
Action On 08/20/18, the firm, icumedical, mailed "URGENT MEDICAL DEVICE RECALL" l notices to consignees. The notice described the product, problem and actions to be taken. If product has been further distributed, the firm requested consignees to notify users. Customers were advised to return affected product only if the blood filter is needed. Customers needing response forms and/or return labels were advised to call 1-800-479-0551. For further inquiries call: 1-866-829-9025.
Quantity in Commerce 2361 Units
Distribution U.S. Distribution in states of: NY, AL, CA, MS, PA, GA, MI, NC, WI, IL, WA, UT and FL.
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.
510(K) Database 510(K)s with Product Code = FMG and Original Applicant = ICU MEDICAL, INC.
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