Maquet recalls infant CPS QPID tubing sets with batch numbers 3000045221-3000084636 due to potential sterility issues during sterilization. Affected units may not meet sterility standards after exposure to ethylene oxide gas.
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 CPS QPID tubing sets that could fail sterility checks during sterilization. This risk means the tubing might not be safe for medical use after standard sterilization processes.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas. This prevents proper gas flow, which could compromise sterility assurance levels for medical use.
Infants receiving medical care using these specific tubing sets. Healthcare providers and hospitals that use the recalled product are most at risk.
Check for batch numbers: 3000045221, 3000049201, 3000054750, 3000062046, 3000065497, 3000067793, 3000069723, 3000072247, 3000075339, 3000080720, 3000084636. The product is labeled as Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID with material code 701055866.
Identify if your tubing set has batch numbers 3000045221 through 3000084636.
The tubing's design may prevent proper humidity and gas flow during sterilization, risking sterility assurance levels for medical use.
Look for batch numbers 3000045221 to 3000084636 on the product label, which is marked as Maquet Getinge-BEQ-TOP 38302 INFANT CPS QPID with material code 701055866.
The recall record does not specify a remedy, so contact Maquet directly for guidance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1543-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1543-2019 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.
