Maquet recalls specific change kits for potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units include batch numbers 3000071199 and 3000081153.
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
Maquet is recalling a specific change kit for extracorporeal circulation use because its design may cause sterility issues during sterilization. This could lead to contamination of medical equipment, posing a risk to patient safety.
The change kit's closed stopcock design may prevent humidity and ethylene oxide gas from flowing properly during sterilization. This could compromise the sterility assurance level, potentially leading to contamination of medical equipment.
Healthcare professionals using the Maquet Getinge-BEQ-T 5915 TCH 3/8 Inch Change Kit for extracorporeal circulation procedures are most at risk. The recall applies to specific batch numbers of the product.
Check for batch numbers 3000071199 or 3000081153 on the Maquet Getinge-BEQ-T 5915 TCH 3/8 Inch Change Kit. The product is used for extracorporeal circulation procedures in medical settings.
Look for batch numbers 3000071199 or 3000081153 on the change kit.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination of medical equipment.
Batch numbers 3000071199 and 3000081153.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1609-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1609-2019 from Maquet. 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.
