—#169675

Product

ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO

FDA product code: DRS — Transducer, Blood-Pressure, Extravascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K052828
Affected lot / code info: Lot/UDI: 3543099/ (01)0 0840619 04494 7 (17) 201001 (30) 01 (10) 3543099

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: ICU Medical, Inc.
Address: 951 Calle, Amanecer San Clemente, California 92673-6212

Distribution

Distribution pattern: U.S.: CA, TX, WI, NY, NC, GA, PA, and NY. Foreign: Canada

Timeline

Recall initiated: 2018-11-27
Terminated: 2022-02-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169675. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.