Maquet recalls specific adult ECC packs due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. 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 adult extracorporeal circulation packs because their design might not allow proper sterilization, risking contamination. This could lead to infections if the equipment is used without being properly sterilized.
The closed stopcock and non-vented cap configuration 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 equipment.
Healthcare professionals using the Maquet Getinge-BO-TOP 36504 Adult ECC Packs for extracorporeal circulation are most at risk if the equipment is not properly sterilized.
Check for the batch numbers: 3000043680, 3000046039, 3000049205, 3000052613, 3000055536, or 3000062791 on the packaging of the Maquet Getinge-BO-TOP 36504 Adult ECC Packs.
Look for batch numbers 3000043680, 3000046039, 3000049205, 3000052613, 3000055536, or 3000062791 on the packaging.
The recall addresses potential sterility issues during sterilization, not normal use. If sterilized correctly, the risk is low.
Check the batch numbers listed in the recall notice. If you have a batch number from the list, contact Maquet for further instructions.
The hazard could lead to contamination if the equipment is not properly sterilized, but the risk is low if the sterilization process is followed correctly.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1573-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1573-2019 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.
