Maquet recalls infant ECC tubing sets that may not maintain sterility during sterilization due to design. Affected units have specific batch numbers. Consumers should contact Maquet for details.
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 infant extracorporeal circulation tubing sets that could fail to stay sterile during sterilization. This risk could lead to infections if the equipment is used without proper sterility.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to infections if the equipment is used without adequate sterility.
Parents and caregivers of infants using extracorporeal circulation (ECMO) equipment are most at risk. The affected units are specific batch numbers of the BEQ-TOP 28901 MCV INFANT ECC tubing sets.
Check for batch numbers: 3000046112, 3000051162, 3000056133, 3000062045, 3000071402, 3000074895, 3000075715, or 3000078940. The product is labeled as BEQ-TOP 28901 MCV INFANT ECC.
Look for batch numbers on the product: 3000046112, 3000051162, 3000056133, 3000062045, 3000071402, 3000074895, 3000075715, or 3000078940.
Reach out to Maquet Cardiovascular for further instructions on handling the affected units.
The affected batch numbers are: 3000046112, 3000051162, 3000056133, 3000062045, 3000071402, 3000074895, 3000075715, and 3000078940.
The tubing's design may prevent proper sterility during sterilization, risking infections if used without adequate sterility.
Contact Maquet Cardiovascular for specific instructions on handling the affected units.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1656-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1656-2019 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.
