Integra Licox Pt02 Monitor Recalled for USB Data Extraction Issues
Integra LifeSciences is recalling 60 Licox Pt02 monitors because the USB port may not allow users to extract trend data as described in the manual.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a functional issue with data extraction rather than a direct physical safety hazard like fire or shock. No injuries or illnesses were reported, fitting the criteria for a moderate severity recall involving a non-critical functional defect.
Plain-English summary
Integra LifeSciences Corporation is recalling 60 units of the Licox Pt02 Monitor, a prescription-only medical device. The recall affects 43 units with catalogue number LCX02 and 17 units with catalogue number LCX02R. The devices were distributed in the United States, including California, the District of Columbia, Florida, Illinois, Indiana, Michigan, Minnesota, North Carolina, New York, Pennsylvania, and Texas.
The recall was initiated after the company received two complaints stating that the USB port on the monitor does not consistently provide users with the ability to extract Pt02 trend data according to the User's Manual. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official recall notice. Users should contact Integra LifeSciences Corporation for instructions on how to proceed with the recall.
The recalled product
- Product
- Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Patient Monitor
- Hazard
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 (20)
- Catalogue #LCX02 - Serial #'s 2130901032
- 2130901050
- 2131001062
- 2131001063
- 2131001086
- 2131001087
- 2131001102
- 2131001110
- 2131001111
- 2131001115
- 2131101124
- 2131101125
- 2131101127
- 2131101129
- 2131101134
- 2131101138
- 2131101151
- 2131101154
- 2140101181
- 2140301222
Distribution
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