Maquet recalls 1/4" ECC PACKs with batch 3000054158 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 a specific 1/4" ECC PACK model because it may not maintain sterility during sterilization. This could lead to infections if used in medical procedures.
The closed stopcock design may trap humidity and ethylene oxide gas during sterilization. This prevents proper sterility assurance, potentially allowing contaminants to remain in the tubing.
Healthcare professionals using the Getinge-BEQ-TOP 33501 1/4" ECC PACK with batch number 3000054158 are most at risk. Patients undergoing procedures with this equipment could face infection risks.
Check for the model 'Getinge-BEQ-TOP 33501 1/4" ECC PACK' and batch number 3000054158. The product is sold by Maquet Cardiovascular, LLC.
Identify the batch number on the packaging to confirm if your unit is affected.
The recall indicates a potential sterility risk during sterilization, so affected units should not be used until the issue is resolved.
The recall does not specify a remedy, so contact Maquet directly for guidance.
Check for the model 'Getinge-BEQ-TOP 33501 1/4" ECC PACK' and batch number 3000054158.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1528-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1528-2019 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.
