Maquet recalls neonate-sized Getinge-BO-T 46200 tubing packs 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 neonate-sized Getinge-BO-T 46200 tubing packs because their design may fail to ensure sterility during sterilization. This could lead to infections if used on patients. The recall affects specific batch numbers.
The tubing's closed stopcock design may trap humidity and ethylene oxide gas during sterilization. This prevents proper sterilization, potentially leading to infections if the tubing is used on patients.
Healthcare facilities using the neonate-sized Getinge-BO-T 46200 tubing packs with the listed batch numbers are affected. Neonatal patients are at higher risk if the tubing is used without proper sterility.
Check for the model 'Getinge-BO-T 46200 3/16" x 1/4" Neonate Pack' with batch numbers 3000043297, 3000045729, 3000046485, 3000049608, 3000052615, 3000054322, 3000056259, or 3000062050.
Verify your tubing pack's batch number against the listed numbers: 3000043297, 3000045729, 3000046485, 3000049608, 3000052615, 3000054322, 3000056259, 3000062050.
The tubing's closed stopcock design may prevent proper sterilization during the process, risking infection if used on patients.
Batch numbers 3000043297, 3000045729, 3000046485, 3000049608, 3000052615, 3000054322, 3000056259, and 3000062050.
The recall does not require immediate discontinuation; 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-1572-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1572-2019 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.
