Maquet recalls Getinge-BO-T 6600 tubing packs with batch 3000073972 due to potential sterility issues during sterilization. Affected units may not meet sterility standards after processing.
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 tubing pack model because it could fail to maintain sterility during sterilization. This means the medical device might not be safe for use after standard sterilization procedures.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas. This can compromise the sterility assurance level, potentially leading to contamination of medical equipment.
Healthcare professionals using this tubing pack for extracorporeal circulation (ECC) procedures are most at risk. The recall applies to specific batch numbers sold under the Getinge-BO-T 6600 brand.
Check for the batch number 3000073972 on the tubing pack. The product is labeled as Maquet Getinge-BO-T 6600 Tubing Pack with material code 701052324.
Look for the batch number 3000073972 and material code 701052324 on the tubing pack.
The tubing pack's design may prevent proper humidity and gas flow during sterilization, risking contamination after processing.
The recall record does not specify a remedy, so no action is required beyond checking the batch number.
The recall indicates potential sterility issues during sterilization, so it should not be used until the batch number is verified.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1520-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1520-2019 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.
