Maquet recalls Ochsner ECC Pack material 709000113 due to potential sterility issues during sterilization. Affected units include batch 3000060038. Consumers should contact Maquet for details.
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 Ochsner ECC Packs with material code 709000113 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 allow contaminants to remain in the fluid path, increasing infection risk.
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 sterile.
Check for the material code 709000113 on the Ochsner ECC Pack. Affected units were sold with batch number 3000060038.
Reach out to Maquet Cardiovascular for specific instructions on handling the recalled item.
The recall indicates a potential sterility risk during sterilization, so it should not be used until the manufacturer provides instructions.
Batch number 3000060038 is affected.
Look for material code 709000113 and batch number 3000060038 on the Ochsner ECC Pack.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1602-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1602-2019 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.
