Maquet recalls specific BEQ-TOP 39202 NICU 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.
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 NICU ECC packs because their sterilization process might not work properly. This could lead to contamination of medical equipment, which is dangerous for patients. The recall affects specific batch numbers of the BEQ-TOP 39202 model.
The closed stopcock design in these packs may block humidity and ethylene oxide gas from flowing through the fluid path during sterilization. This can compromise the sterility assurance level, potentially leading to contamination of medical equipment.
Healthcare facilities using the specific batch numbers of the BEQ-TOP 39202 NICU ECC packs are most at risk. Patients in neonatal intensive care units could be affected if the packs become contaminated.
Check for the batch numbers: 3000043846, 3000047255, 3000052044, 3000061508, 3000074098, 3000078928, or 3000079607. The product is labeled as BEQ-TOP 39202 NICU ECC Pack with material code 701067313R01.
Verify the batch numbers listed in the recall: 3000043846, 3000047255, 3000052044, 3000061508, 3000074098, 3000078928, or 3000079607.
The affected batch numbers are 3000043846, 3000047255, 3000052044, 3000061508, 3000074098, 3000078928, and 3000079607.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination of medical equipment.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1666-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1666-2019 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.
