Maquet recalls specific Getinge-T 8030 4 in High Flow Pigtail tubing due to potential sterility issues during sterilization. Affected units have batch number 3000065493. 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 a specific high-flow pigtail tubing model because it may not maintain sterility during sterilization. This could lead to infections if the tubing is used in medical procedures without proper sterility.
During sterilization, the tubing's closed stopcock configuration may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to infections if the tubing is used in medical procedures without being fully sterile.
Healthcare professionals using the Getinge-T 8030 4 in High Flow Pigtail tubing for extracorporeal circulation (ECC) procedures. Patients using this tubing during surgeries are at risk if sterility is compromised.
Check for the model 'Getinge-T 8030 4 in High Flow Pigtail' with batch number 3000065493. The product is sold by Maquet Cardiovascular, LLC.
Identify the batch number on the tubing to confirm if it matches 3000065493.
The recall indicates a potential sterility risk during sterilization, so it should not be used until the remedy is applied.
Contact Maquet Cardiovascular, LLC directly for instructions on how to handle the affected tubing.
Check for the batch number 3000065493 on the Getinge-T 8030 4 in High Flow Pigtail tubing.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1611-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1611-2019 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.
