ICU Medical recalls certain Spinning Spiros Male Luers due to a molding defect that may cause small leakage in the inactivated position. Affected units include specific lot numbers and red cap models.
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 specific Spinning Spiros Closed Male Luers with red caps because a molding defect could cause small leakage when the device is inactivated. This leakage might lead to fluid administration issues during medical procedures.
A molding defect in the device can cause small amounts of leakage when the luer is in the inactivated position. This leakage might lead to unintended fluid administration or contamination during medical procedures.
Healthcare professionals using the device for fluid administration to patients are most at risk. The recall applies to specific lot numbers and red cap models sold under the product name.
Check for the red cap on the Spinning Spiros Closed Male Luer. Affected units include lot numbers 5135750 and 5142982 as listed in the product description.
Look for the red cap on the Spinning Spiros Closed Male Luer to identify potential affected units.
The product has a molding defect that may cause small amounts of leakage when in the inactivated position.
Lot numbers 5135750 and 5142982 are affected.
The recall record does not specify a remedy.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1568-2021 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1568-2021 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.
