Maquet recalls specific cardioplegia packs due to potential sterility issues during sterilization. Affected units have batch numbers 3000053530 and 3000058323. Contact for return instructions.
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 that may not maintain sterility during sterilization. This could lead to infections if used in medical procedures.
During sterilization, the closed stopcock design may trap humidity and ethylene oxide gas, preventing proper sterility assurance. This could allow contaminants to enter the fluid path, risking infections during surgery.
Healthcare professionals using these packs for heart surgery may be affected. Patients undergoing cardiac procedures using recalled packs face potential infection risks.
Check for batch numbers 3000053530 or 3000058323 on the cardioplegia pack. The product is labeled as Maquet Getinge-BEQ-T 4963 with material code 701067203.
Look for batch numbers 3000053530 or 3000058323 on the cardioplegia pack.
The recalled model is Maquet Getinge-BEQ-T 4963 with material code 701067203.
Batch numbers 3000053530 and 3000058323 are affected.
Check for batch numbers 3000053530 or 3000058323 on the product label.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1583-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1583-2019 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.
