Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific 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 risk-of-harm product (medical device) where sterility cannot be assured, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK custom tubing sets used for extracorporeal circulation. The recall is due to a potential defect in the closed stopcock and non-vented cap configuration. This design may prevent humidity and ethylene oxide gas from flowing into the fluid path during the sterilization process, meaning the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.
The affected product is identified by Batch Number 3000041469. The distribution pattern for these units is nationwide. The source text does not specify the number of units affected or report any illnesses or injuries associated with this recall.
Healthcare facilities and users of these custom tubing sets should stop using the affected units and contact Maquet Cardiovascular for further instructions on how to return or replace the product.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 50100 CHOSA 1/4" ECC PACK Material: 701067837
- 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: 3000041469
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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