ICU Medical recalls certain Oncology Kits with Spinning Spiros due to potential leakage in inactivated position. Affected units may leak small amounts of fluid during use.
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 an oncology kit that includes Spinning Spiros components. The recall is due to a molding defect that could cause small amounts of leakage when the device is in the inactivated position.
The molding defect in the Spinning Spiros components can cause small amounts of leakage when the device is in the inactivated position. This leakage could potentially lead to fluid exposure during medical procedures.
Patients receiving chemotherapy through this kit are most at risk. Healthcare providers using the kit for fluid administration may also be affected.
Check for the product name 'REF CL3538 Oncology Kit w/5" Add-On Set w/ChemoLock Additive Port, Vented Cap'. The lot number 5125294 is associated with this recall.
Verify the product name and lot number to confirm if it matches the recalled items.
Due to a molding defect that may cause small amounts of leakage in the inactivated position of certain Spinning Spiros components.
The recall does not specify a remedy, so check the product details to confirm if it is affected and contact the manufacturer for further instructions.
The recall states potential leakage but does not mention serious injury risks, so the risk is considered low.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1572-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1572-2021 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.
