Maquet recalls specific ECC packs due to potential sterility issues during sterilization. Affected units have batch numbers listed; users should check their product.
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 sterilization may not properly ensure sterility due to tubing design. This could lead to infections if used in medical procedures.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to infections if the pack is used without being fully sterile.
Medical professionals using the Getinge-BEQ-TOP 38900 ECC packs with batch numbers listed. Patients undergoing procedures with these packs face the highest risk.
Check for batch numbers: 3000041396, 3000044053, 3000047317, 3000050887, 3000058131, 3000060487, 3000060723, 3000062458, 3000064724, 3000071815, 3000071817. The product is labeled as Maquet Getinge-BEQ-TOP 38900 ECC PACK with material code 701056368.
Identify your batch number from the list provided in the recall notice.
Batch numbers 3000041396, 3000044053, 3000047317, 3000050887, 3000058131, 3000060487, 3000060723, 3000062458, 3000064724, 3000071815, 3000071817.
The tubing design may prevent proper sterilization, risking infection if the pack is used without being fully sterile.
The recall does not require immediate stoppage; check your batch number and follow the provided steps.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1547-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1547-2019 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.
