Maquet Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling 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 sterility cannot be assured, 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 Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK (Material: 701063071) custom tubing sets for extracorporeal circulation. The recall affects batch numbers 3000044877, 3000045089, and 3000045951, which were distributed nationwide.
The recall is due to a potential defect in the sterilization process. The closed stopcock and non-vented cap configuration may prevent the flow of humidity and 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 devices may not be sterile.
Healthcare facilities and users of these devices should stop using the affected tubing sets and contact Maquet Cardiovascular for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Maquet Getinge-BEQ-TOP 30901 CUSTOM CPB PACK Material:701063071
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Surgical Tubing
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: 3000044877 3000045089 3000045951
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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