ICU Medical recalls specific lots of Oncology Kit with Sprios male luer components due to potential leakage in inactivated position. Affected units may cause medication exposure risks.
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
ICU Medical is recalling certain lots of their Oncology Kit with Sprios male luer components because of a molding defect that could cause small leaks when the components are inactivated. This leakage might expose users to medication during handling, which could be harmful.
The molding defect in the Sprios male luer components may cause small amounts of medication to leak when the components are inactivated. This leakage could expose healthcare workers or patients to medication during handling, potentially causing harm.
Healthcare professionals using the specific lot numbers of this Oncology Kit for cytotoxic medication preparation are most at risk. Patients receiving these medications could potentially be exposed if leaks occur.
Check for the lot number 5118610 on the packaging of the Oncology Kit. The product includes Sprios male luer components with a red cap and bag spike with Clave additive port.
Look for the lot number 5118610 on the packaging of the Oncology Kit.
The product may have a molding defect that could cause small leaks when inactivated, so it is not safe to use without checking the lot number.
Check the lot number on the packaging; if it is 5118610, contact ICU Medical for instructions.
The recalled product has the lot number 5118610 and includes Sprios male luer components with a red cap and bag spike with Clave additive port.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1565-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1565-2021 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.
