ICU Medical recalls specific IV tubing sets due to potential leaks from spinning spike adapters, which could cause infusion delays, contamination, or blood exposure. Affected models include Spiros and Clave sets with reference numbers listed.
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
ICU Medical is recalling certain IV tubing sets that may leak fluids due to a defect in the spinning spike adapters. This could lead to delayed infusions, contamination, or exposure to patient blood or hazardous medications.
A molding defect in the spinning spike adapters can cause leaks when the adapter spins. This may lead to fluid leakage, which could delay medication infusions, contaminate the fluid path, expose patients to hazardous medications, or cause blood loss or air entry into the fluid line.
Patients using IV therapy with the recalled tubing sets, particularly those in hospitals or clinics. Healthcare workers handling these sets are at risk of exposure to patient blood or medications.
Check for the following model names and reference numbers: Spiros Bag Spike Adapter (REF: 20123-01), Clave 20 Drop Admin Sets (REF: CH3035, CH3135, CH3240, etc.), and other specific IV sets listed in the recall notice. The products were sold with the reference numbers provided.
Look for reference numbers like CH3035, CH3135, CH3240, or 20123-01 on the tubing set packaging or labels.
Reach out to ICU Medical directly for confirmation of the specific model and reference numbers that match your tubing set.
The spinning spike adapters have a molding defect that can cause leaks when the adapter spins, potentially leading to fluid leakage.
Fluid leakage could cause delays in medication infusions, contamination of the fluid path, exposure to hazardous medications, blood loss, or air entry into the fluid line.
No, but you should check the reference numbers on your tubing sets to confirm if they are affected. The recall does not require immediate discontinuation but requires verification.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0701-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0701-2021 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.
