Maquet recalls BEQ-TOP 46700 Adult ECC Packs with batch numbers 3000076856 and 3000077891 due to potential sterility issues during sterilization. Affected units may not meet sterility standards if humidity/ethylene oxide gas flow is blocked.
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 adult ECC packs because their tubing design might prevent proper sterilization, risking infections. This affects hospitals and medical facilities using these packs for extracorporeal circulation.
The tubing's closed stopcock configuration may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could lead to the stopcock ports not meeting sterility assurance levels, potentially causing infections.
Hospitals and medical facilities using the recalled BEQ-TOP 46700 Adult ECC Packs with batch numbers 3000076856 or 3000077891 are most at risk. These packs are used for extracorporeal circulation procedures.
Check for batch numbers 3000076856 or 3000077891 on the BEQ-TOP 46700 Adult ECC Pack. The product is sold by Maquet Getinge under the brand name Maquet.
Look for batch numbers 3000076856 or 3000077891 on the BEQ-TOP 46700 Adult ECC Pack.
Batch numbers 3000076856 and 3000077891 are affected.
Check for batch numbers 3000076856 or 3000077891 on the BEQ-TOP 46700 Adult ECC Pack.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1664-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1664-2019 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.
