Maquet recalls pediatric ECC packs with batch numbers 3000041127-3000081601 due to potential sterility issues during sterilization. Affected units may not meet sterility standards after processing.
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 pediatric extracorporeal circulation packs that could fail to meet sterility standards after sterilization. This poses a risk of infection during medical procedures if the equipment is used without proper sterility.
During sterilization, the closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterilization. This could lead to the equipment not meeting sterility standards, increasing infection risk during medical procedures.
Pediatric patients requiring extracorporeal circulation support, particularly those using the specific batch numbers listed. Healthcare providers using these packs for medical procedures are most at risk.
Check for batch numbers: 3000041127, 3000049458, 3000061103, 3000065550, 3000071378, 3000075338, or 3000081601 on the packaging. The product is a pediatric extracorporeal circulation pack from Maquet.
Look for batch numbers 3000041127 through 3000081601 on the packaging.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, potentially leading to equipment that doesn't meet sterility standards.
Check for batch numbers 3000041127, 3000049458, 3000061103, 3000065550, 3000071378, 3000075338, or 3000081601 on the packaging.
The recall does not specify a remedy, so contact Maquet directly for guidance on next steps.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1516-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1516-2019 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.
