Maquet recalls specific batch numbers of Getinge-BEQ-TOP 24202 Adult ECC tubing for potential sterility issues during sterilization. Affected units may not meet sterility standards if improperly configured.
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 batches of Getinge-BEQ-TOP 24202 Adult ECC tubing due to a risk that the tubing may not maintain sterility during sterilization. This could lead to infections if the tubing is used in medical procedures.
During sterilization, the tubing's closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level, potentially leading to infections if the tubing is used in medical procedures.
Healthcare professionals using the Getinge-BEQ-TOP 24202 Adult ECC tubing in medical procedures are most at risk if the tubing is not properly sterilized.
Check for batch numbers: 3000057379, 3000063707, 3000066885, 3000071785, 3000071806, or 3000073164. The product is labeled as Maquet Getinge-BEQ-TOP 24202 ADULT ECC.
Look for batch numbers 3000057379, 3000063707, 3000066885, 3000071785, 3000071806, or 3000073164 on the tubing packaging.
The tubing's closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing during sterilization, potentially compromising sterility assurance.
Batch numbers 3000057379, 3000063707, 3000066885, 3000071785, 3000071806, and 3000073164.
The recall does not specify a stop-use action; check batch numbers to determine if your tubing is affected.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1532-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1532-2019 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.