Maquet recalls Getinge-BO-TOP 35503 SGD PACK with batch numbers 3000056047, 3000058250, 3000066199 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 Getinge-BO-TOP 35503 SGD PACK tubing sets because their sterilization process might not ensure sterility. 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, preventing proper sterility assurance. This could lead to infections if the tubing is used in medical procedures.
Healthcare professionals using these tubing sets for extracorporeal circulation (ECC) procedures. Patients undergoing such treatments are at risk if the tubing isn't properly sterile.
Check for batch numbers 3000056047, 3000058250, or 3000066199 on the packaging. The product is labeled as Maquet Getinge-BO-TOP 35503 SGD PACK with material code 701067668.
Look for batch numbers 3000056047, 3000058250, or 3000066199 on the packaging.
The product may not be sterile after sterilization, which could lead to infections. Do not use until the recall is addressed.
Check the batch numbers on the packaging. If they match the recalled numbers, stop using it and contact Maquet for further instructions.
Look for batch numbers 3000056047, 3000058250, or 3000066199 on the Maquet Getinge-BO-TOP 35503 SGD PACK packaging.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1588-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1588-2019 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.
