Maquet recalls specific ECC custom tubing sets due to potential sterility issues during sterilization. Affected models include BEQ-TOP 25003 with batch numbers 3000070816-3000087051. Stop using if you own these items.
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 custom tubing sets for extracorporeal circulation (ECC) because they may not maintain sterility during sterilization. This could lead to infections if the tubing is used in medical procedures without proper sterility.
During sterilization, the tubing's closed stopcock configuration may block humidity and ethylene oxide gas from flowing into the fluid path. This prevents the tubing from meeting sterility standards, increasing infection risk.
Healthcare professionals using these tubing sets for extracorporeal circulation procedures are most at risk. Patients receiving treatments with these sets could face infection if sterility is compromised.
Check for the model BEQ-TOP 25003 with batch numbers 3000070816, 3000072682, 3000074736, 3000077083, 3000080988, 3000082175, or 3000087051. These tubing sets are used in extracorporeal circulation systems.
Identify the batch number on the tubing set to confirm if it is affected by this recall.
The tubing set may not maintain sterility during sterilization due to a closed stopcock configuration that blocks humidity and ethylene oxide gas flow.
The recall does not specify a remedy, so contact Maquet directly for guidance on next steps.
Yes, affected batch numbers include 3000070816, 3000072682, 3000074736, 3000077083, 3000080988, 3000082175, and 3000087051.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1658-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1658-2019 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.
