Maquet recalls specific ECC PACK units due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have listed batch numbers.
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 ECC PACK units because their design might not allow proper sterilization, potentially leading to contamination. This could affect medical procedures requiring sterile equipment.
The closed stopcock configuration may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, risking contamination of the equipment.
Healthcare professionals using the Maquet Getinge-BEQ-TOP 24105 ECC PACK for extracorporeal circulation. Those handling the specific batch numbers listed are most at risk.
Check for the batch numbers: 3000051271, 3000057632, 3000062460, 3000066202, 3000069076, 3000073425, 3000076761, or 3000080703. The product is labeled as Maquet Getinge-BEQ-TOP 24105 ECC PACK with material code 701064757.
Look for the batch numbers listed: 3000051271, 3000057632, 3000062460, 3000066202, 3000069076, 3000073425, 3000076761, or 3000080703.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination of the equipment.
Batch numbers: 3000051271, 3000057632, 3000062460, 3000066202, 3000069076, 3000073425, 3000076761, 3000080703.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1559-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1559-2019 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.
