ICU Medical recalls 1.7 ml bag spikes with potential fluid leaks causing infusion delays, contamination, or blood exposure. Affected units include specific lot numbers from the recall.
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 1.7 ml bag spikes that may leak due to a molding defect. This could cause infusion delays, contamination, or exposure to patient blood. Affected units have specific lot numbers.
A molding defect in the bag spike may cause spinning male luer fittings to leak. This leakage could delay medication delivery, contaminate the fluid path, or expose patients to blood or hazardous medications.
Healthcare professionals using these medical devices for patient infusions are most at risk. Patients receiving treatments through these devices could face complications.
Check for the product name 'Appx 1.7 ml Bag Spike w/Integrated Cl: 2 Drop-In Spiros' with lot numbers 4741955 or 4764010. The recall applies to specific batches sold under reference number CH3260.
Look for lot numbers 4741955 or 4764030 on the product packaging.
The bag spikes have a molding defect that can cause spinning male luer fittings to leak.
Fluid leakage may cause infusion delays, contamination, exposure to hazardous medications, blood loss, or patient blood exposure.
Check for lot numbers 4741955 or 4764030 on the product packaging.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0710-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0710-2021 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.
