Maquet recalls BO-TOP 48400 tubing sets due to potential sterility issues during sterilization. Affected units have specific batch numbers; contact for remedy.
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 BO-TOP 48400 tubing sets that may not maintain sterility during sterilization. This could lead to infections if used in medical procedures.
During sterilization, the tubing's closed stopcock design may trap humidity and ethylene oxide gas. This prevents proper sterility assurance, potentially allowing contaminants to remain in the tubing.
Healthcare professionals using these tubing sets for extracorporeal circulation (ECC) procedures are most at risk. Patients receiving such treatments could be affected if the tubing fails to stay sterile.
Check for batch numbers: 3000045085, 3000047033, 3000051653, 3000056258, or 3000062266. The product is labeled as BO-TOP 48400 OR PACK with material code 701064327R01.
Look for batch numbers 3000045085, 3000047033, 3000051653, 3000056258, or 3000062266 on the tubing set.
The tubing set may not maintain sterility during sterilization due to its closed stopcock design, which can trap humidity and ethylene oxide gas.
Batch numbers 3000045085, 3000047033, 3000051653, 3000056258, and 3000062266 are affected.
The recall does not specify a stop-use instruction; check batch numbers to determine if your unit is affected.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1659-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1659-2019 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.
