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 is classified as FDA Class II and involves a risk of harm (compromised sterility) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling specific custom tubing sets for extracorporeal circulation (ECC). The affected products are identified by the description "Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831" and include batch numbers 3000066688 and 3000080800. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is due to a potential issue with the sterilization process. During sterilization, the closed stopcock and non-vented cap configuration may prevent the flow of humidity or ethylene oxide gas into the fluid path between the closed port and the cap. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, meaning the sterility of these specific components may be compromised.
The products were distributed nationwide. Healthcare facilities and users of these custom tubing sets should stop using the affected units and contact Maquet Cardiovascular for further instructions or replacement.
The recalled product
- Product
- Maquet Getinge-BEQ-T 44200 MAYO PULMONARY P Material: 701064831
- 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: 3000066688 3000080800
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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