Maquet recalls specific batch numbers of Open Heart 14605 devices due to potential sterility issues during sterilization. Affected units may not maintain proper sterility assurance levels if used with certain tubing configurations.
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 specific batches of Open Heart 14605 devices because improper sterilization could compromise sterility. This means the medical device might not be safe for use after sterilization, risking infections.
During sterilization, the closed stopcock configuration may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination of the device if not properly sterilized.
Medical professionals using the Open Heart 14605 device for extracorporeal circulation may be affected. Patients undergoing procedures with these devices could face infection risks if the sterility is compromised.
Check for the batch numbers: 3000047035, 3000051157, 3000056254, 3000059729, 3000062036, or 3000063395. The device model is Maquet Getinge-BO-TOP 14605 Open Heart with material code 701067372.
Identify the batch number on the device label to see if it matches the affected numbers: 3000047035, 3000051157, 3000056254, 3000059729, 3000062036, or 3000063395.
The closed stopcock configuration may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination and compromising sterility assurance.
Check the batch number on the device label. If it matches the affected numbers, contact Maquet for guidance on safe handling or disposal.
The recall record does not specify a remedy or fix. Affected units should be checked and handled according to the manufacturer's guidance if needed.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1586-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1586-2019 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.
