Maquet recalls 1/4" ECC PACKs with batch 3000044423 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 a specific type of cardiovascular tubing pack because it might not stay sterile after being sterilized. This could lead to infections during medical procedures if the tubing is used improperly.
During sterilization, the tubing's closed stopcock design can trap humidity and ethylene oxide gas. This prevents proper sterility assurance, potentially allowing bacteria to grow in the tubing.
Healthcare professionals using the Getinge-BEQ-TOP 8207 1/4" ECC PACK with batch number 3000044423 are most at risk. Patients receiving procedures using this tubing may face infection risks.
Check for the batch number 3000044423 on the packaging. The product is a 1/4" ECC PACK from Maquet Getinge-BEQ-TOP 8207 series.
Look for batch number 3000044423 on the packaging to confirm if the item is affected.
The product may not meet sterility standards after sterilization, so it should not be used until a replacement is obtained.
Check the batch number on the packaging. If it matches 3000044423, contact Maquet for a replacement.
Using this tubing could lead to infections during medical procedures if it is not properly sterile after processing.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1592-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1592-2019 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.
