Maquet recalls BEQ-TOP 40010 Open Heart Packs with batch numbers 3000058180 and 3000062474 due to potential sterility issues during sterilization. Affected units may not meet sterility standards if improperly configured.
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 open heart packs that could fail to meet sterility standards during sterilization. This risk affects surgical equipment used in heart surgeries.
During sterilization, the closed stopcock configuration may block humidity and ethylene oxide gas from reaching the fluid path. This could compromise the sterility assurance level of the stopcock ports, potentially leading to infections.
Surgical teams using the recalled open heart packs for heart surgery are most at risk. The affected units are identified by specific batch numbers.
Check for batch numbers 3000058180 or 3000062474 on the BEQ-TOP 40010 Open Heart Packs. The product is sold by Maquet Getinge.
Look for batch numbers 3000058180 or 3000062474 on the BEQ-TOP 40010 Open Heart Packs.
Batch numbers 3000058180 and 3000062474.
Check for batch numbers 3000058180 or 3000062474 on the BEQ-TOP 40010 Open Heart Packs.
The recall does not provide a fix; affected units should be checked and discarded if they have the listed batch numbers.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1668-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1668-2019 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.
