Maquet recalls Getinge-BEQ-TOP 35503 SGD packs with batch 3000079609 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 tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterilization. This could compromise the sterility of the medical device, increasing infection risk.
Healthcare facilities using the recalled Getinge-BEQ-TOP 35503 SGD packs with batch number 3000079609 are most at risk. Patients undergoing extracorporeal circulation procedures could be affected.
Check for the batch number 3000079609 on the Getinge-BEQ-TOP 35503 SGD pack. The product is sold by Maquet Cardiovascular, LLC.
Verify the batch number on the product label; affected units have batch 3000079609.
The recall indicates a potential sterility risk during sterilization, so affected units should not be used until the issue is resolved.
Check the batch number on the Getinge-BEQ-TOP 35503 SGD pack; affected units have batch 3000079609.
The recall does not specify a remedy, so contact Maquet Cardiovascular, LLC for guidance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1672-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1672-2019 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.
