Maquet recalls specific cardioplegia packs due to potential sterility issues during sterilization. The closed stopcock design may prevent proper humidity and gas flow, risking contamination. Affected units have batch numbers 3000053531, 3000060033, or 3000067120.
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 certain cardioplegia packs because their design may cause sterility issues during sterilization. This could lead to contaminated medical equipment if used in heart surgery.
The closed stopcock design in these packs may prevent humidity and ethylene oxide gas from flowing properly during sterilization. This could compromise the sterility of the equipment, increasing infection risk during surgery.
Healthcare professionals using these cardioplegia packs for heart surgery are most at risk. Patients undergoing cardiac procedures with the recalled packs could face infection.
Check for batch numbers 3000053531, 3000060033, or 3000067120 on the cardioplegia pack. The product is labeled as Maquet Getinge-BO-T 52360 Cardioplegia Pack.
Look for batch numbers 3000053531, 3000060033, or 3000067120 on the cardioplegia pack.
The closed stopcock design may prevent proper humidity and ethylene oxide gas flow during sterilization, risking contamination of the equipment.
Check the batch numbers on the product. If they match 3000053531, 3000060033, or 3000067120, contact Maquet for instructions.
The recall addresses sterility risks during surgery, not direct injury. Serious injury is not mentioned in the recall.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1604-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1604-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
