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, potentially 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 (medical device) where the sterility cannot be assured, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Maquet Getinge-BEQ-TOP 15705 custom tubing sets used for extracorporeal circulation. The recall involves specific batch numbers: 3000044566, 3000046394, 3000049202, 3000054550, 3000058043, 3000060239, 3000066276, 3000069368, 3000071833, 3000074339, 3000080701, and 3000081598. The product is made of material 701051122 and 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 the sterilization process. This issue means that the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, creating a potential risk of non-sterile equipment being used in medical procedures.
Healthcare facilities and users of these specific tubing sets should stop using the affected units immediately. The source text does not specify a particular action for consumers, as these are medical devices typically managed by healthcare professionals. Users should contact Maquet Cardiovascular, LLC for further instructions on how to handle or return the affected products.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 15705 Material: 701051122
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
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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