ICU Medical recalls Transpac IV Monitoring Kit with Safeset Reservoir. Pressure tubing separation may delay therapy or cause blood loss, air embolism, or contamination. Affected units have specific lot numbers.
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 their Transpac IV Monitoring Kit with Safes: pressure tubing separation could delay therapy or cause blood loss, air embolism, or contamination. This is a serious risk for patients using the kit in medical settings.
The tubing can separate between the sampling port and high pressure tubing on certain lots. This separation might delay critical therapy or cause blood loss, air embolism, or contamination of the fluid path.
Healthcare professionals using the Transpac IV Monitoring Kit with Safeset Reservoir are most at risk. Patients receiving IV therapy with this kit could be affected if the tubing separates.
Check for the lot number 3543099 or the UDI code 0840619 04494 7 (17) 201001 (30) 01 (10) 3543099 on the product label. The kit includes 60" tubing with a Safeset Reservoir and blood sampling port.
Look for the lot number 3543099 or UDI code 0840619 04494 7 (17) 201001 (30) 01 (10) 3543099 on the product label.
Pressure tubing separation between the sampling port and high pressure tubing on certain lots could delay therapy or cause blood loss, air embolism, or contamination.
Check for the lot number 3543099 or UDI code 0840619 04494 7 (17) 201001 (30) 01 (10) 3543099 on the product label.
The recall does not specify a remedy, so contact ICU Medical directly for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1071-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1071-2019 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.
