Maquet recalls specific batches of Getinge-BEQ-TOP 5900 3/8 Quadrox iD Packs due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination.
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 specific batches of Getinge-BEQ-TOP 5900 3/8 Quadrox iD Packs because their sterilization process might not ensure sterility. This could lead to infections if used in medical procedures.
During sterilization, the closed stopcock design prevents humidity and ethylene oxide gas from flowing into the fluid path. This can compromise the sterility assurance level, potentially causing contamination.
Healthcare professionals using these packs for extracorporeal circulation (ECC) procedures are most at risk. Patients receiving these packs during surgery may face infection risks.
Check for batch numbers: 3000048233, 3000048397, 3000054333, 3000058183, 3000069469, or 3000074100. The product is labeled as Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack with material code 701050228.
Look for batch numbers: 3000048233, 3000048397, 3000054333, 3000058183, 3000069469, or 3000074100.
The closed stopcock design may prevent proper humidity and gas flow during sterilization, risking contamination and compromising sterility assurance.
Batch numbers 3000048233, 3000048397, 3000054333, 3000058183, 3000069469, and 3000074100.
The recall does not specify a stop-use instruction; check batch numbers to determine if your product is affected.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1507-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1507-2019 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.
