Maquet recalls specific bridge kits 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 a specific bridge kit model because its design could lead to contamination during sterilization. This affects medical devices used in extracorporeal circulation procedures.
The bridge kit's closed stopcock 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.
Healthcare professionals using the recalled bridge kit for extracorporeal circulation procedures. Patients undergoing such treatments are at risk if the kit is used without proper sterility.
Check for the model number 48002 and batch number 3000058085 on the bridge kit. The product was sold with the material code 709000444.
Identify the model number 48002 and batch number 3000058085 on the bridge kit.
The closed stopcock design may prevent proper humidity and gas flow during sterilization, risking contamination of the device.
Check the model number and batch number to see if it matches the recalled items. The recall does not specify a remedy.
The recall indicates a potential sterility risk, but no specific injury mechanism is described.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1622-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1622-2019 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.
