Maquet recalls specific BEQ-TOP 37200 E-Circuit Bioline Heparin tubing sets due to potential sterility issues during sterilization. Affected units have batch numbers 3000076762, 3000077899, 3000078013, or 3000084649.
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 certain BEQ-TOP 37200 E-Circuit Bioline Heparin tubing sets because they 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 and non-vented cap design may block humidity and ethylene oxide gas from flowing into the fluid path. This prevents proper sterility assurance, potentially causing infections in medical procedures.
Healthcare professionals using the BEQ-TOP 37200 E-Circuit Bioline Heparin tubing sets for extracorporeal circulation. Patients receiving treatments with these sets are at risk of infection.
Check for batch numbers: 3000076762, 3000077899, 3000078013, or 3000084649. The product is labeled as Maquet Getinge BEQ-TOP 37200 E-Circuit Bioline Heparin.
Look for batch numbers 3000076762, 3000077899, 3000078013, or 3000084649 on the tubing set.
The tubing set may not maintain sterility during sterilization due to a design issue that blocks humidity and ethylene oxide gas flow, risking infections.
Batch numbers 3000076762, 3000077899, 3000078013, and 3000084649.
The recall does not require immediate stoppage; healthcare professionals should check batch numbers and follow the provided action steps.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1652-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1652-2019 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.
