Maquet recalls specific small adult cardiac surgery tubing sets 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 3000045083 and 3000046399.
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 small adult cardiac surgery tubing sets that could become contaminated during sterilization. This happens because the tubing's closed stopcock design may block humidity and gas flow, compromising sterility. If you have the affected batch numbers, stop using the product immediately.
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 can compromise the sterility assurance level, potentially leading to contamination of the surgical materials.
Cardiac surgery patients and medical staff using the specific tubing sets with batch numbers 3000045083 and 3000046399. Those in hospitals or clinics using the recalled product are most at risk.
Check for batch numbers 3000045083 or 3000046399 on the Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material. The product is sold under the brand Maquet.
Immediately stop using the affected tubing sets with batch numbers 3000045083 or 3000046399.
Batch numbers 3000045083 and 3000046399.
The closed stopcock design may prevent proper humidity and gas flow during sterilization, risking contamination.
Look for batch numbers 3000045083 or 3000046399 on the Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1595-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1595-2019 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.
