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U.S. Department of Health and Human Services

Class 2 Device Recall ICU Medical

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  Class 2 Device Recall ICU Medical see related information
Date Initiated by Firm November 27, 2018
Create Date March 28, 2019
Recall Status1 Terminated 3 on February 01, 2022
Recall Number Z-1070-2019
Recall Event ID 81743
Product Classification Transducer, blood-pressure, extravascular - Product Code DRS
Product ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO
Code Information Lot/UDI:  3514084/ (01)0 0840619 03747 5 (17) 201001 (30) 01 (10) 3514084; 3550279/ (01)0 0840619 03747 5 (17) 201001 (30) 01 (10) 3550279
Recalling Firm/
Manufacturer		 ICU Medical, Inc.
951 Calle Amanecer
San Clemente CA 92673-6212
Manufacturer Reason
for Recall		 Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.
FDA Determined
Cause 2		 Process design
Action On 11/27/18, Urgent Medical Device Recall notices were sent via traceable mailing to customers informing them to discontinue use and distribution of the affected product. In addition, customers were asked to quarantine and return affected product, and to complete and return response forms. Customers were instructed to inform all potential users of the product within their organization, and if the product had been further distributed, to immediately notify these additional customers. Customers with additional questions were encouraged to call: Global Complaint Management @ 1-844-654-7780 (ProductComplaintsPP@icumed.com), Medical Information @ 1-800-241-4002 option 6 (medinfo_us@icumed.onmicrosoft.com), or Customer Care @ 1-949-366-4208.
Quantity in Commerce 5000
Distribution U.S.: CA, TX, WI, NY, NC, GA, PA, and NY. Foreign: Canada
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.
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