Maquet recalls small patient 1/4 tubing sets due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have specific batch numbers.
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 small patient 1/4 tubing sets that could become contaminated during sterilization. This happens because the tubing's design may prevent proper humidity and gas flow, which is critical for maintaining sterility.
During sterilization, the tubing's closed stopcock configuration may block humidity and ethylene oxide gas from flowing into the fluid path. This prevents proper sterility assurance, potentially allowing contaminants to remain in the system.
Healthcare workers using these tubing sets for extracorporeal circulation (ECC) procedures are most at risk. Patients receiving ECC treatments with affected units could face contamination.
Check for the model 'Getinge-BO-TOP 20705 SMALL PATIENT 1/4' with batch numbers 3000048716, 3000054549, 3000061302, 3000067224, 3000070815, 3000072509, or 3000076464.
Verify the batch numbers listed: 3000048716, 3000054549, 3000061302, 3000067224, 3000070815, 3000072509, or 3000076464.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination of the tubing.
Batch numbers 3000048716, 3000054549, 3000061302, 3000067224, 3000070815, 3000072509, and 3000076464.
The recall does not provide a remedy; affected units should be checked and replaced if necessary.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1526-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1526-2019 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.
