ICU Medical recalls 1 unit per cavity of Iced Thermoset Closed-Loop Injectate Delivery System for cold injectate due to potential leakage from a defective thermoset check valve. Affected units have specific lot numbers and expiration dates.
Potential for leakage due to defect in the thermoset check valve component.
ICU Medical is recalling a small number of Iced Thermoset Closed-Loop Injectate Delivery Systems for cold injectate because a defect in the thermoset check valve could cause leakage. This is a minor issue that doesn't pose a serious risk to users.
The thermoset check valve component has a defect that could lead to leakage of the injectate. This leakage might cause contamination or improper delivery of cold medical fluids, but it does not pose a significant risk of injury or serious harm under normal use.
Healthcare professionals who use this medical device for cold injectate delivery may be affected. Patients using the device are at low risk due to the small number of units recalled and the nature of the defect.
Check for the product name 'Iced Thermoset Closed-Loop Injectate Delivery System' with lot numbers 3580033-3585775 and 3598139-3656680. The expiration date is listed as 12/1/2020 or 1/1/2021 depending on the lot.
Identify the lot number and expiration date on the device to determine if it is affected.
ICU Medical recalls 1 unit per cavity with specific lot numbers listed in the record.
The thermoset check valve component has a defect that could cause leakage of the injectate.
The recall record does not specify a remedy; users should check if their device is affected and contact the manufacturer if needed.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0663-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0663-2019 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.
