Maquet recalls specific batches of Getinge-BEQ-TOP 32100 Adult Custom PAC tubing sets due to potential sterility issues during sterilization. Affected units may not maintain proper sterility assurance levels.
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 batches of Getinge-BEQ-TOP 32100 Adult Custom PAC tubing sets because the design may prevent proper sterilization. This could lead to the tubing not being sterile after processing, which is dangerous for medical use.
The tubing's closed stopcock and non-vented cap design may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This prevents the tubing from achieving the required sterility assurance level, potentially leading to contamination.
Healthcare professionals using these tubing sets for extracorporeal circulation (ECC) procedures are most at risk. Patients receiving these sets during surgery could be exposed to unsterile materials.
Check for the batch numbers listed: 3000043291, 3000044425, 3000046811, 3000047912, 3000052203, 3000053795, 3000059174, 3000062478, 3000066197, 3000067469, 3000070703, 3000074122, 3000075896. The product is labeled as Maquet Getinge-BEQ-TOP 32100 ADULT CUSTOM PAC.
Look for the batch numbers listed in the recall: 3000043291, 3000044425, 3000046811, 3000047912, 3000052203, 3000053795, 3000059174, 3000062478, 3000066197, 3000067469, 3000070703, 3000074122, 3000075896.
The tubing's closed stopcock and non-vented cap design may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization, which could lead to inadequate sterility assurance.
Check the batch numbers listed in the recall. If your tubing has one of these batch numbers, contact Maquet for instructions.
This is a potential sterility issue that could lead to contamination, but the recall indicates the risk is low as the hazard is specific to the sterilization process and not immediate harm.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1533-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1533-2019 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.
