Maquet recalls specific small patient 3/8 tubing sets due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination.
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 small patient 3/8 tubing sets because their design might not allow proper humidity and gas flow during sterilization. This could lead to contamination and compromise sterility assurance.
The tubing's closed stopcock and non-vented cap configuration may block humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This prevents the system from maintaining proper sterility assurance levels, potentially leading to contamination.
Healthcare professionals using the specific tubing sets for extracorporeal circulation (ECC) systems are most at risk. Patients receiving these sets during procedures could be affected if contamination occurs.
Check for the model 'Getinge-BO-TOP 20700 SMALL PATIENT 3/8' with material code 701050966. Affected units have batch numbers 3000063810, 3000068490, 3000071784, or 3000076463.
Identify the model number and batch numbers listed in the recall notice to confirm if your tubing set is affected.
The closed stopcock and non-vented cap design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination and compromising sterility assurance.
Batch numbers 3000063810, 3000068490, 3000071784, and 3000076463 are affected.
Check for the model 'Getinge-BO-TOP 20700 SMALL PATIENT 3/8' with material code 701050966 and the listed batch numbers.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1512-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1512-2019 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.
