Maquet recalls Getinge-BEQ-TOP 250011/4 tubing sets with batch numbers 3000068802, 3000071398, 3000074190, 3000076543 due to potential sterility issues during sterilization.
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 Getinge-BEQ-TOP 250011/4 tubing sets because they may not maintain sterility during sterilization. This could lead to infections if used in medical procedures.
During sterilization, the tubing's closed stopcock design may block humidity and ethylene oxide gas from flowing into the fluid path. This can compromise the sterility assurance level, potentially causing infections.
Medical professionals using these tubing sets for extracorporeal circulation (ECC) procedures are affected. Patients undergoing such procedures are at risk if the tubing is not properly sterilized.
Check for batch numbers 3000068802, 3000071398, 3000074190, or 3000076543 on the tubing sets. These are part of the Getinge-BEQ-TOP 250011/4 model with a weight limit of less than 20 kg.
Look for batch numbers 3000068802, 3000071398, 3000074190, or 3000076543 on the tubing sets.
The tubing set may not maintain sterility during sterilization due to its closed stopcock design, which can block humidity and ethylene oxide gas from flowing into the fluid path.
Batch numbers 3000068802, 3000071398, 3000074190, and 3000076543 are affected.
The recall does not specify a fix; users should check if their tubing has the affected batch numbers and contact the manufacturer if needed.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1645-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1645-2019 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.
