Disposable Patient Circuit with Precision Flow System recalled for excessive condensation
Vapotherm has recalled 5,869 Low Flow Disposable Patient Circuits for the Precision Flow System due to reports of excessive condensation that may lead to rainout.
What this means for you
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: This is a Class II medical device recall involving a respiratory patient circuit with reported potential for excessive condensation and rainout. No illnesses, injuries, or deaths are reported in the source. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Vapotherm is recalling 5,869 Low Flow Disposable Patient Circuits (Product Code PF-DPC-LOW) for use with the Precision Flow System. The circuits are affected by reports of excessive condensation in certain lots, which may lead to excessive rainout—moisture accumulation within the breathing circuit.
The recall affects multiple lot numbers distributed worldwide, including throughout the United States and the United Kingdom. The affected lot numbers include LFVMA8503, LFVMA8504, LFVMA8567, LFVLE8568, LFTL41015, LFVLC8399, LFVLE8495, LFVMA8502, LFTL41261, LNTL41544, LFVLE8588, LFVMA8507, LFVLE8494, LFTL41263, and LFTL41262.
Healthcare facilities and patients using the Precision Flow System with these patient circuits should refer to the FDA notice for further guidance on the recall.
The recalled product
- Product
- Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
- Manufacturer
- Vapotherm
- Hazard
- excessive-condensation
- rainout
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 (5)
- UDI-DI: 00841737104971
- Lot Numbers: LFVMA8503
- LFVMA8504
- LFVMA8567
- UDI-DI: 00841737104978
Distribution
Distributed nationwide across the United States.
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