Maquet recalls pediatric cardiac surgery packs with batch 3000059175 due to potential sterility issues during sterilization. Affected units may not meet sterility standards after processing.
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 pediatric cardiac surgery packs with batch number 3000059175 because the tubing design might not maintain sterility during sterilization. This could lead to infections if the equipment is used without proper sterility.
The tubing's closed stopcock design can trap humidity and ethylene oxide gas during sterilization. This may prevent the equipment from meeting sterility standards, increasing infection risk during surgery.
Healthcare professionals using the Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack with batch 3000059175 are most at risk. Patients undergoing cardiac surgery may be affected if the equipment is used without proper sterility.
Check for the batch number 3000059175 on the Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack. The product was sold with this specific batch number.
Look for batch number 3000059175 on the product label.
The recall indicates a potential sterility risk during sterilization, so it is not safe to use without the remedy.
Check for batch number 3000059175 on the Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack.
The recall does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1596-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1596-2019 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.
