ICU Medical recalls 1 unit per Cavity #3 Cavity Deep/20 pieces per case with potential leakage due to a thermoset check valve defect. 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 specific model of room temperature injectate delivery system because a defect in the check valve could cause leakage. This poses a risk of contamination or infection if the system is used in medical settings.
The thermoset check valve component has a defect that could lead to leakage of medical fluids. This leakage might cause contamination or infection if the system is used in clinical settings where sterile conditions are critical.
Healthcare facilities using the recalled model, particularly those with the specific lot numbers listed. Patients receiving treatments through this system are at risk if the leakage occurs.
Check for the product name 'Thermoset Room Temperature Closed Loop Injectate Delivery System' with lot numbers 3591489, 3598125, 3608570, 3610798, 3618041, or 3656677, and expiration date 01/01/2021.
Identify the lot number and expiration date on the product label to confirm if it is affected.
Reach out to ICU Medical directly for guidance on next steps if the product is confirmed affected.
1 unit per Cavity #3 Cavity Deep/20 pieces per case with specific lot numbers listed in the recall notice.
Leakage of medical fluids could lead to contamination or infection in clinical settings.
The recall record does not specify a remedy; affected units should be checked and contacted with ICU Medical.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0661-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0661-2019 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.
