Maquet recalls specific Open Heart Packs due to potential sterility issues during sterilization. The closed stopcock design may prevent humidity and ethylene oxide gas flow, risking contamination. Affected units include batch numbers 3000042627, 3000047034, and 3000058143.
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 specific Open Heart Packs that may not maintain sterility during sterilization. This could lead to contamination if the packs are used in medical procedures. The affected units have specific batch numbers.
The closed stopcock design in these packs may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, potentially leading to contamination of the medical device.
Healthcare professionals using the Open Heart Packs for extracorporeal circulation procedures are most at risk. Patients receiving these packs during surgery could be affected if the sterility is compromised.
Check for batch numbers 3000042627, 3000047034, or 3000058143 on the packaging. The product is labeled as 'BO-TOP 38803 OPEN HEART PACK W' with specific material codes.
Look for batch numbers 3000042627, 3000047034, or 3000058143 on the packaging.
The closed stopcock design may prevent humidity and ethylene oxide gas from flowing during sterilization, risking contamination of the medical device.
Check the batch numbers on the packaging. If you have a batch number listed above, contact Maquet for further instructions.
The recall addresses potential contamination during sterilization, not direct injury risks. The danger level is low risk.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1669-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1669-2019 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.
