Maquet recalls Ochsner ECC Ancillary Pack (709000115) due to potential sterility issues during sterilization. Affected units have batch numbers 3000043613 or 3000076067.
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 Ancillary Packs that may not maintain sterility during sterilization. This could lead to infections if used improperly in medical procedures.
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, potentially causing infections.
Healthcare professionals using the Ochsner ECC Ancillary Pack for extracorporeal circulation. Patients receiving treatments with this equipment are at risk of infection.
Check for batch numbers 3000043613 or 3000076067 on the Ochsner ECC Ancillary Pack (model 51502).
Look for batch numbers 3000043613 or 3000076067 on the Ochsner ECC Ancillary Pack (model 51502).
The model number is 51502 (Ochsner ECC Ancillary Pack).
Batch numbers 3000043613 and 3000076067.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1603-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1603-2019 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.
