Maquet recalls specific ECC tubing sets 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 3000045170, 3000058051, 3000062455, 3000065508.
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 ECC tubing sets because their design may prevent proper sterilization, risking contamination. This affects medical devices used in extracorporeal circulation. Users should check the batch numbers listed to see if their unit is affected.
The tubing's closed stopcock configuration may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, potentially leading to contamination of the device.
Healthcare professionals using the Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 tubing sets for extracorporeal circulation. Those with batch numbers 3000045170, 3000058051, 3000062455, or 3000065508 are most at risk.
Check the batch numbers on the tubing: 3000045170, 3000058051, 3000062455, or 3000065508. The product name is Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 with material code 701051179.
Look for batch numbers 3000045170, 3000058051, 3000062455, or 3000065508 on the tubing.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination of the device.
Batch numbers 3000045170, 3000058051, 3000062455, and 3000065508.
No action is required if your batch number is not listed. Only affected units should check the batch numbers.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1515-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1515-2019 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.
