Maquet recalls specific ECC PACK models due to potential sterility issues during sterilization. Affected units have batch numbers 3000043296-3000066887. Contact for remedy.
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 certain ECC PACKs because their sterilization process might not properly ensure sterility. This could lead to infections during medical procedures if the equipment isn't properly sterilized.
During sterilization, the closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path. This could compromise the sterility assurance level, potentially causing infections during medical procedures.
Healthcare professionals using the Maquet Getinge-BEQ-TOP 26402 ECC PACK for extracorporeal circulation. Patients undergoing procedures with this equipment are at risk if the packs aren't properly sterilized.
Check for batch numbers 3000043296, 3000046809, 3000047251, 3000050480, 3000054805, 3000060727, or 3000066887 on the packaging. The product is labeled as Maquet Getinge-BEQ-TOP 26402 ECC PACK with material code 701062310.
Look for batch numbers 3000043296, 3000046809, 3000047251, 3000050480, 3000054805, 3000060727, or 3000066887 on the packaging.
Batch numbers 3000043296, 3000046809, 3000047251, 3000050480, 3000054805, 3000060727, and 3000066887.
The recall addresses a potential risk of compromised sterility during sterilization, which could lead to infections if the equipment isn't properly sterilized.
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-1548-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1548-2019 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.
