Maquet recalls Getinge-BEQ-TOP 5502 ECC packs with batch numbers 3000074733 and 3000081599 due to potential sterility issues after sterilization.
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 improper sterilization could lead to contamination. This affects medical devices used in extracorporeal circulation.
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 of the stopcock ports.
Healthcare professionals using these ECC packs for extracorporeal circulation are most at risk. Patients using the devices may be affected if the packs are not properly sterilized.
Check for batch numbers 3000074733 or 3000081599 on the Maquet Getinge-BEQ-TOP 5502 ECC packs. The product is sold under the brand Maquet.
Look for batch numbers 3000074733 or 3000081599 on the product label.
The recalled product is the Maquet Getinge-BEQ-TOP 5502 ECC Pack with batch numbers 3000074733 and 3000081599.
The closed stopcock configuration may prevent proper humidity and gas flow during sterilization, risking contamination.
Check the batch numbers on the product label. If they match 3000074733 or 3000081599, contact Maquet for further instructions.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1640-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1640-2019 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.
