Maquet recalls Getinge-BEQ-T 5914 TCH 1/2 inch change kits with batch numbers 3000071200, 3000081154, 3000084780 due to potential sterility issues during sterilization. Affected users should check their batch numbers.
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 specific 1/2 inch change kits used in extracorporeal circulation systems because they may not maintain sterility during sterilization. This could lead to infections if the kits are used without proper sterility assurance.
During sterilization, the closed stopcock design may block humidity and ethylene oxide gas from flowing into the fluid path. This prevents the system from ensuring sterility, which could lead to infections if the kits are used without proper sterility assurance.
Healthcare professionals using the Getinge-BEQ-T 5914 TCH 1/2 inch change kits for extracorporeal circulation systems. Those with batch numbers 3000071200, 3000081154, or 3000084780 are most at risk.
Check the batch numbers on the kit: 3000071200, 3000081154, or 3000084780. The product is a 1/2 inch change kit for extracorporeal circulation systems made by Maquet Getinge-BEQ-T 5914 TCH.
Look for batch numbers 3000071200, 3000081154, or 3000084780 on the kit.
The closed stopcock design may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization, which could compromise sterility assurance.
Batch numbers 3000071200, 3000081154, and 3000084780.
The recall does not require immediate discontinuation; check your batch number to see if you are affected.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1610-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1610-2019 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.
