Maquet recalls Getinge-BEQ-TOP 31604 ECC tubing with batch 3000083880 due to potential sterility issues during sterilization. Affected units may not meet sterility standards after processing.
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 ECC tubing sets because they might not stay sterile after sterilization. This could lead to infections during medical procedures if the tubing isn't properly sterilized.
During sterilization, the tubing's closed stopcock design may block humidity and ethylene oxide gas from reaching the fluid path. This can cause the tubing to fail sterility checks, potentially leading to infections during medical procedures.
Healthcare professionals using the tubing for extracorporeal circulation (ECC) in medical procedures. Patients receiving treatments through these tubes are at risk if the tubing isn't sterile.
Check for the model number 31604 CHKD 1/4" ECC with material code 709000518. Affected units have batch number 3000083880.
Identify the model number 31604 CHKD 1/4" ECC with material code 709000518 and batch number 3000083880.
The recall states that the tubing may not meet sterility standards after sterilization, so it should not be used until the remedy is applied.
Look for the model number 31604 CHKD 1/4" ECC with material code 709000518 and batch number 3000083880.
The recall does not specify a remedy, so contact Maquet for guidance on safe handling or disposal.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1627-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1627-2019 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.
