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, 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 medical device where sterility cannot be assured, posing a risk of infection (risk-of-harm product), 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 custom tubing sets for extracorporeal circulation (ECC). The recall involves the Maquet Getinge-BO-TOP 14605 OPEN HEART WITHOU Material (701067372). The affected batch numbers are 3000047035, 3000051157, 3000056254, 3000059729, 3000062036, and 3000063395. The products were 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 that the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, potentially leaving the device non-sterile.
Healthcare facilities and users should stop using the affected tubing sets and contact Maquet Cardiovascular, LLC for further 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-BO-TOP 14605 OPEN HEART WITHOU Material: 701067372
- 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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