ICU Medical recalls specific lots of Hotline Fluid Warming Sets due to potential leakage. Affected units may cause fluid leaks during medical use. Contact for details.
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
ICU Medical is recalling specific lots of Hotline Fluid Warming Sets because they may leak. This could lead to improper fluid delivery during medical procedures, posing a risk to patient safety.
The device may leak due to inadequate bonding between the tubing and the return connector. This leakage could cause improper fluid delivery to patients, potentially leading to complications during medical procedures.
Healthcare providers using the Hotline Fluid Warming Set for blood and IV fluid warming are most at risk. Patients receiving treatments through these devices may be affected if the device leaks.
Check for Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349. The device is a single-use medical device for warming blood and IV fluids.
Identify if your device has one of the affected Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349.
The devices may leak due to inadequate bonding between the tubing and the return connector, which could lead to improper fluid delivery during medical procedures.
Check for Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349.
Contact ICU Medical for instructions on how to handle the device. The recall does not specify a remedy.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2759-2026 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-2759-2026 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.