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ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (6...

FDA Recall #Z-1070-2019 — Class II — November 27, 2018

Recall #Z-1070-2019 Date: November 27, 2018 Classification: Class II Status: Terminated

Product Description

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

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.

Recalling Firm

ICU Medical, Inc. — San Clemente, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

5000

Distribution

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

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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