Maquet recalls Getinge-BEQ-T 46500 PRIME PACKs with batch numbers 3000043849 and 3000046392 due to potential sterility issues during sterilization.
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-T 46500 PRIME PACKs that may not maintain sterility during sterilization. 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, increasing infection risk.
Healthcare professionals using these packs for extracorporeal circulation (ECC) procedures. Patients undergoing such treatments are at risk if the packs are not properly sterilized.
Check for batch numbers 3000043849 or 3000046392 on the Getinge-BEQ-T 46500 PRIME PACKs. These packs were sold with the specified material code 701065823.
Look for batch numbers 3000043849 or 3000046392 on the Getinge-BEQ-T 46500 PRIME PACK.
The closed stopcock design may prevent proper humidity and gas flow during sterilization, risking contamination.
Check the batch numbers on the product. If they match 3000043849 or 3000046392, contact Maquet for further instructions.
The recall addresses potential infection risk, not direct injury. The hazard is low risk as it relates to sterility assurance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1575-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1575-2019 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.
