Use caution Medical device recall · FDA · Published November 27, 2018

ICU Medical Transpac IV Kit Recall: Pressure Tubing Separation Risk

ICU Medical recalls Transpac IV Monitoring Kit with Safeset Reservoir and Blood Sampling Port due to risk of pressure tubing separation causing delayed therapy or blood loss, air embolism, or contamination.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1070-2019Medical device ICU Medical ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmICU Medical, Inc.951 Calle Amanecer · San Clemente, CA 92673-6212

✎ GovInfoNow plain-language explainer

ICU Medical is recalling Transpac IV Monitoring Kits with Safeset Reservoir and Blood Sampling Port. The recall is because certain lots of tubing can separate, which might delay treatment or cause blood loss, air embolism, or contamination. Read more at govinfonow.com/recall/69426-icu-medical-transpac-iv-kit-recall-pressure-tubing-separation-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/69426-icu-medical-transpac-iv-kit-recall-pressure-tubing-separation-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1070-2019

Cite this page

“ICU Medical Transpac IV Kit Recall: Pressure Tubing Separation Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69426-icu-medical-transpac-iv-kit-recall-pressure-tubing-separation-risk. Based on FDA recall #Z-1070-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1070-2019%22&limit=1).

The FDA announced on 2018-11-27 that ICU Medical, Inc. is recalling Transpac IV Monitoring Kits due to pressure tubing separation risks. The hazard could lead to therapy delays, blood loss, air embolism, or contamination. This voluntary Class II recall involves 5,000 units distributed in the U.S. and Canada.

How to tell if you have it

Brand: ICU Medical
Product: 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
Lot/UDI: 3514084/ (01)0 0840619 03747 5 (17) 201001 (30) 01 (10) 3514084
Lot/UDI: 3550279/ (01)0 0840619 03747 5 (17) 201001 (30) 01 (10) 3550279

The hazard

Reports indicate pressure tubing separation between the sampling port and high pressure tubing on certain lots of extravascular blood pressure transducers. This failure could lead to delay in therapy, and in rare circumstances, blood loss, air embolism, or contamination of the fluid path.

Context

GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since 2017-06-15. Recent brand recalls include a 2026-08-20 CADD Yellow Medication Cassette Reservoir Recall for leakage risk and a 2026-06-24 Hotline Fluid Warming Set Recall for leakage in specific lots. Other recent recalls of similar products include Medtronic DLP Retrograde Cannula Recall (2026-04-21), Medtronic DLP Cannula Recall (2026-04-21), and B Braun Medical Blood Set Recall (2025-10-29).

How to tell if you have this one

Check for the Transpac IV Monitoring Kit with Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, REF: 01C-42640-06. Lot numbers 3514084 and 3550279 are affected.

Brand
ICU Medical
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
U.S.: CA, TX, WI, NY, NC, GA, PA, and NY. Foreign: Canada

Recall number	Product, codes & lots	Quantity
Z-1070-2019	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; 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	5000
Z-1071-2019	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; Lot/UDI: 3543099/ (01)0 0840619 04494 7 (17) 201001 (30) 01 (10) 3543099	280
Z-1072-2019	ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO; Lot/UDI: 3529857/ (01)0 0840619 04495 4 (17) 200901 (30) 01 (10) 3529857	N/A

Based on the official FDA remedy

What to do — step by step

Check for Separation
Inspect the tubing for separation between the sampling port and high pressure tubing.

Where it went and when

Where it was distributed

Distributed in 7 states, and outside the U.S.

FDA distribution: “U.S.: CA, TX, WI, NY, NC, GA, PA, and NY. Foreign: Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Georgia, New York, North Carolina, Pennsylvania, Texas, Wisconsin.

Recall timeline

FDA terminated this recall 3.2 years after the firm started it.

Nov 27, 2018Firm started the recall
Mar 28, 2019FDA classified it Class II
Apr 3, 2019Published in FDA’s Enforcement Report
Feb 1, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More ICU Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/69426-icu-medical-transpac-iv-kit-recall-pressure-tubing-separation-risk">ICU Medical Transpac IV Kit Recall: Pressure Tubing Separation Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1070-2019 (November 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1070-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.