Maquet recalls Mayo Pulmonary Packs with batch numbers 3000041415, 3000044885, and 3000077738 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 Mayo Pulmonary Packs with specific batch numbers because their design can fail to ensure sterility during sterilization. This could lead to infections if the packs are used in medical procedures.
The closed stopcock configuration in these packs may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This can compromise the sterility assurance level, increasing infection risks during medical procedures.
Healthcare professionals using these packs for extracorporeal circulation (ECC) procedures are most at risk. Patients receiving such treatments could face infection if the packs are not properly sterilized.
Check for batch numbers 3000041415, 3000044885, or 3000077738 on the Mayo Pulmonary Pack packaging. The product is labeled as Maquet Getinge-BO-T 44201 with material code 701064834.
Look for batch numbers 3000041415, 3000044885, or 3000077738 on the product packaging.
Batch numbers 3000041415, 3000044885, and 3000077738 are affected.
The closed stopcock configuration may prevent proper humidity and gas flow during sterilization, risking infection.
Check for batch numbers 3000041415, 3000044885, or 3000077738 on the Mayo Pulmonary Pack packaging.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1563-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1563-2019 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.
