ICU Medical recalls specific ChemoLock drip chamber sets that may leak due to a molding defect, risking medication exposure or blood loss. Affected units include certain model numbers and lot numbers.
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 specific ChemoLock drip chamber sets that could leak due to a molding defect. This leakage might delay medication delivery, contaminate fluids, or expose patients to hazardous medications or blood.
A molding defect in the drip chamber can cause spinning male luer fittings to leak. This leakage might delay medication infusion, contaminate the fluid path, expose patients to hazardous medications, cause blood loss, or lead to air entering the fluid line.
Healthcare professionals using the recalled ChemoLock drip chambers for patient medication administration are most at risk. Patients receiving treatments through these devices could face exposure to hazardous medications or blood loss.
Check for model numbers: 011-CL3011, 011-CL3020, CL-35, CL3951, CL3962, CL3999. Also look for lot numbers: 4867937, 4751234, 4799262, 4894789, 4787230, 4867947, 4897075, 4720480, 4735684, 4758456, 4775068, 4794504, 4860043, 4799897, 4787234, 4808045, 4860044.
Identify the model number on the product (e.g., 011-CL3011, CL3962) to confirm if it is affected.
Reach out to ICU Medical directly for assistance with the recall if you have the affected product.
A molding defect causes spinning male luer fittings to leak, potentially leading to fluid leakage.
Check for model numbers: 011-CL3011, 011-CL3020, CL-35, CL3951, CL3962, CL3999, or lot numbers listed in the recall notice.
Contact ICU Medical directly for assistance with the recall; no specific remedy is provided in the recall notice.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0707-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0707-2021 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.
