Maquet recalls Getinge-BO-TOP 26300 Custom Packs with batch numbers 3000043848, 3000050583, 3000050645, 3000053626, 3000054146 due to potential sterility issues during sterilization.
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 custom packs of Getinge-BO-TOP 26300 tubing for extracorporeal circulation. The tubing may not maintain sterility during sterilization because of its design, which could lead to contamination.
The tubing's closed stopcock and non-vented cap design may prevent humidity and ethylene oxide gas from flowing into the fluid path during sterilization. This could compromise the sterility assurance level, potentially leading to contamination of the tubing.
Medical professionals using the Getinge-BO-TOP 26300 Custom Packs for extracorporeal circulation systems. Those with the specific batch numbers listed are most at risk.
Check for the batch numbers: 3000043848, 3000050583, 3000050645, 3000053626, or 3000054146 on the packaging. The product is a custom pack of Getinge-BO-TOP 26300 tubing for extracorporeal circulation.
Look for batch numbers 3000043848, 3000050583, 3000050645, 3000053626, or 3000054146 on the packaging.
The tubing's design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination.
Batch numbers 3000043848, 3000050583, 3000050645, 3000053626, and 3000054146.
The recall record does not specify a remedy.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1513-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1513-2019 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.
