Maquet recalls Getinge-BO-TOP 30901 Custom CPB Packs with batch 3000061506 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 a specific custom CPB pack used in heart-lung machines because a design flaw could cause sterility problems during sterilization. This means the medical device might not be safe for use after being sterilized, risking infections during surgery.
The custom tubing set's closed stopcock design may trap humidity and ethylene oxide gas during sterilization. This prevents proper gas flow, which could compromise the sterility of the device and lead to infections during surgery.
Healthcare facilities using the Getinge-BO-TOP 309:30901 Custom CPB Pack with batch number 3000061506 are most at risk. Patients undergoing heart-lung machine procedures could face infection if the device fails to maintain sterility.
Check for the batch number 3000061506 on the Getinge-BO-TOP 30901 Custom CPB Pack. The product was sold by Maquet Cardiovascular, LLC.
Look for the batch number 3000061506 on the Getinge-BO-TOP 30901 Custom CPB Pack.
The recall states that the product may not meet sterility standards after sterilization, so it is not safe for use without the remedy.
The recall does not specify a remedy, so contact Maquet Cardiovascular, LLC for guidance.
Check for the batch number 3000061506 on the Getinge-BO-TOP 30901 Custom CPB Pack.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-1538-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-1538-2019 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.
