Maquet 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 of stopcock ports.
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 medical device where sterility cannot be assured, posing a risk of harm (infection) even though no specific illnesses or injuries have been reported in the source text.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Custom Tubing Sets for Extracorporeal Circulation (ECC), specifically the Maquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI (Material: 701065512). The recall affects batch number 3000056132 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. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially compromising the sterility of the device.
Healthcare facilities and users of these devices should stop using the affected tubing sets and contact Maquet Cardiovascular for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 31204 CUSTOM PACK PEDI Material: 701065512
- 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: 3000056132
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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