Maquet recalls specific Getinge-BEQ-TOP 17207 3/8 ECC PACK units due to potential sterility issues during sterilization. Affected units have batch numbers listed in the recall notice.
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 17207 3/8 ECC PACK units because their design may fail to ensure sterility during sterilization. This could lead to infections if the equipment is used without proper sterility.
The closed stopcock configuration in these units may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, increasing infection risk if the equipment is used without proper sterilization.
Medical device users who own or use the recalled Getinge-BEQ-TOP 17207 3/8 ECC PACK units with the listed batch numbers are affected. Healthcare professionals using these units for extracorporeal circulation are at highest risk.
Check for the batch numbers: 3000043292, 3000047704, 3000050576, 3000052263, 3000060362, 3000065492, 3000066201, or 3000071202 on the product label. The product is a 3/8 ECC PACK with material code 701049346.
Look for batch numbers listed: 3000043292, 3000047704, 3000050576, 3000052263, 3000060362, 3000065492, 3000066201, or 3000071202.
The affected batch numbers are: 3000043292, 3000047704, 3000050576, 3000052263, 3000060362, 3000065492, 3000066201, and 3000071202.
The closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization, potentially compromising sterility assurance.
Check the product label for the batch numbers listed. If you have a matching batch number, contact Maquet for further instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1502-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1502-2019 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.
