Maquet recalls 33500 3/8" ECC PACKs with batch 3000056255 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 ECC PACKs because their design might not maintain sterility during sterilization. This could lead to infections if used improperly.
The closed stopcock configuration in these packs may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, potentially leading to infections if the equipment is used without proper sterility.
Healthcare professionals using the Getinge-BEQ-TOP 33500 3/8" ECC PACKs for extracorporeal circulation. Those handling the specific batch number 3000056255 are most at risk.
Check for the model 'Getinge-BEQ-TOP 33500 3/8" ECC PACK' with batch number 3000056255. The product is sold under Maquet Cardiovascular, LLC.
Look for batch number 3000056255 on the product label.
The recall indicates a potential sterility risk during sterilization, so it is not recommended for use until the remedy is applied.
The recall does not specify a remedy, so contact Maquet Cardiovascular, LLC directly for guidance.
Check for the model 'Getinge-BEQ-TOP 33500 3/8" ECC PACK' with batch number 3000056255.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1527-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1527-2019 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.
