Maquet recalls Getinge-T 22706 Sample Manifold (material 701054912) due to potential sterility issues during sterilization. Affected units have batch numbers starting with 3000055636.
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 sample manifold model due to a risk that could compromise sterility during sterilization. This affects medical devices used in extracorporeal circulation setups.
During sterilization, the closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path. This could lead to unassured sterility levels in the stopcock ports.
Healthcare professionals using this sample manifold in extracorporeal circulation systems. The risk is low as it relates to sterility assurance during sterilization processes.
Check for the model 'Getinge-T 22706 Sample Manifold' with material code 701054912. Affected units have batch numbers starting with 3000055636.
Identify the model number and batch number to confirm if your item is affected.
The closed stopcock configuration may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization, potentially compromising sterility assurance.
Batch numbers starting with 3000055636.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1536-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1536-2019 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.
