Maquet Getinge recalls specific custom tubing sets for extracorporeal circulation 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 Getinge is recalling two specific custom tubing sets used in extracorporeal circulation. The issue could lead to contamination during sterilization because the tubing's design might prevent proper humidity and gas flow, affecting 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 could compromise the sterility assurance level, potentially leading to contamination of the tubing.
Healthcare professionals using these custom tubing sets for extracorporeal circulation systems are likely affected. Patients receiving treatments through these systems could be at risk if the tubing becomes contaminated during sterilization.
Check for model numbers 701053941R01 or 701053941R02 with batch numbers listed in the recall notice. These tubing sets are used in extracorporeal circulation systems and were sold with specific batch numbers.
Identify the model number and batch numbers listed in the recall notice to confirm if your tubing set is affected.
The tubing set's closed stopcock design may prevent proper humidity and gas flow during sterilization, risking contamination and affecting sterility assurance.
Batch numbers 3000051652, 3000054808, 3000058733, 3000062473, 3000071201, 3000073170, 3000075123 for model 701053941R01 and 3000076148, 3000081600 for model 701053941R02 are affected.
The recall notice does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Maquet Getinge to request your refund or repair — edit it as you like.
Subject: Recall Z-1646-2019 — Maquet Getinge Maquet Getinge Hello, I own a Maquet Getinge that is covered by recall Z-1646-2019 from Maquet Getinge. 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.
