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.
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.
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.
The tubing can separate between the sampling port and high pressure tubing on certain lots. This separation might delay critical therapy, or in rare cases, cause blood loss, air embolism, or contamination of the fluid path.
Healthcare professionals using the Transpac IV Monitoring Kit with Safeset Reservoir and Blood Sampling Port are most at risk. Patients receiving IV therapy with this specific kit could be affected if the tubing separates.
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.
Inspect the tubing for separation between the sampling port and high pressure tubing.
The recalled product is ICU Medical Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, REF: 01C-42640-06.
In rare circumstances, tubing separation could lead to delayed therapy, blood loss, air embolism, or contamination of the fluid path.
Check for lot numbers 3514084 or 3550279 on the Transpac IV Monitoring Kit with Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, REF: 01C-42640-06.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1070-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1070-2019 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
