CLASS II Device recall · Reported 3 Apr 2019 · FDA Enforcement Report

Transpac IV Monitoring Kit With Safeset Reservoir recalled

ICU Medical is recalling Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, distributed in 7 states. The recall was initiated on 27 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot/UDI: 3543099/ (01)0 0840619 04494 7 (17) 201001 (30) 01 (10) 3543099

Quantity recalled280

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1071-2019
FDA event ID: 81743
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Terminated
Recall initiated: 27 Nov 2018
FDA classified: 28 Mar 2019
Reported: 3 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

27 Nov 2018	Recall initiated by company
28 Mar 2019	Classified by FDA	+121 days
3 Apr 2019	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

California Georgia North Carolina New York Pennsylvania Texas Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot/UDI: 3543099/ (01)0 0840619 04494 7 (17) 201001 (30) 01 (10) 3543099

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 81743

This product is part of a recall event; the main page for the event is Transpac IV Monitoring Kit With Safeset Reservoir recalled.

Reported	Class	Recall	Company	Reason	Where
3 Apr 2019	CLASS II	Transpac IV Monitoring Kit With Safeset Reservoir recalled	ICU Medical	Other	7 states
3 Apr 2019	CLASS II	Transpac IV Monitoring Kit With Safeset Reservoir recalled	ICU Medical	Other	7 states

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