Maquet recalls specific Ochsner ECC Adult 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 3000048398, 3000075385, or 3000075472.
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 Ochsner ECC Adult Packs with specific batch numbers because the tubing design might not allow proper sterilization, risking contamination. This could lead to infections if the equipment isn't properly sterilized.
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, potentially leading to contamination of the equipment.
Healthcare professionals using the Ochsner ECC Adult Packs for extracorporeal circulation. Those with the specific batch numbers listed are most at risk.
Check the batch numbers on the packaging: 3000048398, 3000075385, or 3000075472. The product is labeled as Maquet Getinge-BO-T 51502 Ochsner ECC Adult Pack.
Look for batch numbers 3000048398, 3000075385, or 3000075472 on the packaging.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination.
Batch numbers 3000048398, 3000075385, and 3000075472.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1614-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1614-2019 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.
