Maquet Getinge Custom Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility cannot be assured, which is a high-risk hazard for infection, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK custom tubing sets for extracorporeal circulation. The recall involves specific batch numbers: 3000049611, 3000058052, 3000062459, and 3000066196. The product was distributed nationwide.
The recall was initiated because the closed stopcock and non-vented cap configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path during sterilization. This issue means the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, posing a potential risk of non-sterile equipment being used in medical procedures.
Healthcare facilities and users of these products should stop using the affected tubing sets immediately. Maquet Cardiovascular is the recalling firm and is responsible for managing the recall process.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 33704 ECC 1/4" PACK Material: 701054150
- Manufacturer
- Maquet Cardiovascular, LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch Numbers: 3000049611 3000058052 3000062459 3000066196
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 183 recalled by Maquet Cardiovascular, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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