Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw 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 medical device where the sterility assurance level cannot be assured, posing a risk of harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Custom Tubing Sets for Extracorporeal Circulation (ECC) (Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK, Material:701064804). The recall affects batch numbers 3000057680, 3000066687, 3000075125, 3000075898, and 3000080799. 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. As a result, the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured, which may compromise the sterility of the device.
Healthcare facilities and consumers who possess these specific batch numbers should stop using the products and contact Maquet Cardiovascular, LLC for further instructions on return or replacement.
The recalled product
- Product
- Maquet Getinge-BEQ-T 27904 3/8 TRANSPORT PACK Material:701064804
- 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: 3000057680 3000066687 3000075125 3000075898 3000080799
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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