Maquet recalls Getinge-BEQ-TOP 35503 SGD packs with batch numbers 3000048720-3000075283 due to potential sterility issues during sterilization. Affected units may not meet sterility standards after processing.
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 Getinge-BEQ-TOP 35503 SGD 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 may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could allow contaminants to remain in the tubing, risking infections during medical procedures.
Healthcare professionals using these packs for extracorporeal circulation (ECC) procedures. Patients receiving such treatments are at risk if the packs are not properly sterilized.
Check for batch numbers: 3000048720, 3000058736, 3000063950, 3000070973, 3000072680, or 3000075283 on the pack. The product is a Getinge-BEQ-TOP 35503 SGD pack with material code 701068797.
Look for batch numbers 3000048720, 3000058736, 3000063950, 3000070973, 3000072680, or 3000075283 on the pack.
The closed stopcock design may prevent proper humidity and gas flow during sterilization, risking contamination and infection during medical procedures.
Batch numbers 3000048720, 3000058736, 3000063950, 3000070973, 3000072680, and 3000075283.
The recall does not require immediate discontinuation; check batch numbers to determine if your unit 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-1593-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1593-2019 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.
