Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, compromising sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (sterile medical device) where the sterility assurance level cannot be verified, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific lots of Maquet Getinge Custom Tubing Sets for Extracorporeal Circulation (ECC). The recall is due to a potential defect in the closed stopcock and non-vented cap configuration. During the sterilization process, this configuration may prevent the flow of humidity and ethylene oxide gas into the fluid path between the closed port and the non-vented cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured.
The affected product is identified by the following batch numbers: 3000060743, 3000066277, 3000069078, 3000073171, 3000074176, 3000076468, 3000080999, 3000081905, and 3000085277. The product was distributed nationwide. The source text does not specify the number of units affected or report any illnesses or injuries associated with the use of these devices.
Healthcare facilities and consumers should check their inventory for the specific batch numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Users should contact Maquet Cardiovascular, LLC for further instructions on the recall process.
The recalled product
- Product
- Maquet Getinge- BO-T 41301 BUMC ECC PACK Material: -701065209R01
- Manufacturer
- Maquet Cardiovascular, LLC
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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