ICU Medical recalls 1 unit per case of Iced Thermoset Closed-Loop Injectate Delivery System 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 because a defect in the thermoset check valve could cause leakage. This recall affects medical devices used for cold injectates and may pose a risk of contamination or injury if the device leaks.
The thermoset check valve component has a defect that could lead to leakage of the cold injectate. This leakage might cause contamination or injury if the device fails during medical procedures.
Healthcare professionals using the Iced Thermoset Closed-Loop Injectate Delivery System for cold injectates are most at risk. The recall affects specific units with particular lot numbers and expiration dates.
Check for the product name 'Iced Thermoset Closed-Loop Injectate Delivery System' with lot numbers 3593903 or 3598129 and an expiration date of 12/01/2020.
Identify the lot number and expiration date on the device to confirm if it is affected.
The recall involves 1 unit per case with specific lot numbers 3593903 and 3598129.
The expiration date for the affected units is 12/01/2020.
The recall notice 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-0662-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0662-2019 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.
