Maquet recalls BO-TOP 13901 Rapid Response Universal Pk (batch 3000077890, 3000079608) due to potential sterility issues during sterilization. Affected units may not meet sterility standards.
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 BO-TOP 13901 Rapid Response Universal Pk units because their tubing design might not maintain sterility during sterilization. This could lead to infections if used in medical procedures.
During sterilization, the tubing's closed stopcock configuration may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could lead to contamination if the tubing is used in medical procedures.
Healthcare facilities using the recalled tubing sets for extracorporeal circulation (ECC) are most at risk. Patients undergoing procedures with these units could face infection risks.
Check for batch numbers 3000077890 or 3000079608 on the BO-TOP 13901 Rapid Response Universal Pk. The product is sold by Maquet Getinge.
Look for batch numbers 3000077890 or 3000079608 on the tubing set.
The tubing's design may prevent proper sterility during sterilization, risking contamination in medical procedures.
The recall record does not specify a remedy, so contact Maquet Getinge for guidance.
The recall indicates a potential sterility risk, but the record does not describe a specific safety hazard like injury or death.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1651-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1651-2019 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.
