Maquet recalls Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK with batch 3000041469 due to potential sterility issues during sterilization. Affected units may not maintain proper sterility assurance levels.
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 a specific cardiovascular tubing set because it may not maintain sterility during sterilization. This could lead to infections if used in medical procedures without proper sterilization.
During sterilization, the closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level of the tubing, potentially leading to infections if used without proper sterilization.
Healthcare professionals using the Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK for extracorporeal circulation. Patients undergoing procedures with this tubing are at risk if the tubing isn't properly sterilized.
Check for the model number 'Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK' and batch number '3000041469'. The product is sold by Maquet Cardiovascular, LLC.
Identify the model number and batch number to confirm if your item is affected.
The recall indicates a potential risk during sterilization, but the product may still be safe if properly sterilized. However, the manufacturer recommends checking for affected units.
The recall does not specify a remedy, so you should check the product details to see if it matches the affected model and batch number.
Look for the model number 'Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK' and batch number '3000041469' on the product.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1589-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1589-2019 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.
