Maquet recalls Small Patient CI tubing sets due to potential sterility issues during sterilization. The closed stopcock design may prevent humidity and ethylene oxide gas flow, risking contamination. Affected units have specific batch numbers.
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 Small Patient CI tubing sets that could become contaminated during sterilization because the design might block humidity and ethylene oxide gas flow. This affects the sterility assurance of the tubing, which is critical for medical use.
The tubing's closed stopcock and non-vented cap design may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level (SAL) of the stopcock ports, potentially leading to contamination.
Healthcare professionals using these tubing sets for extracorporeal circulation (ECC) procedures. Patients using the equipment are at risk if the tubing becomes contaminated during sterilization.
Check for the model 'Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI' with batch numbers 3000065552, 3000070971, 3000074623, 3000076634, or 3000080868.
Identify if your tubing set has batch numbers 3000065552, 3000070971, 3000074623, 3000076634, or 3000080868.
The closed stopcock/non-vented cap configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization, risking contamination.
Check for the model 'Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI' with batch numbers 3000065552, 3000070971, 3000074623, 3000076634, or 3000080868.
The recall does not specify a remedy; check batch numbers and contact Maquet if you have the affected model.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1519-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1519-2019 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.
