Integra Recalls Camino ICP Catheters for MRI Safety Labeling
Integra LifeSciences is recalling Camino Intracranial Pressure Monitoring Kits to update labeling indicating they are unsafe in MR environments.
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, but the source text identifies the issue as a labeling correction regarding MR safety without reporting any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Integra LifeSciences Corp. is recalling the Camino Intracranial Pressure (ICP) Monitoring Catheters, specifically catalog numbers 110-4B, 110-4G, 110-4H, and 110-4L. The recall involves 28,752 units distributed across numerous countries, including the United States, European nations, and regions in Asia and South America.
The reason for the recall is revised labeling to indicate that the devices are unsafe in a Magnetic Resonance (MR) environment. The FDA has classified this as a Class II recall. The source text does not report any specific injuries, illnesses, or deaths associated with this labeling issue.
Healthcare providers and facilities should check their inventory for the affected catalog numbers and lot numbers listed in the official recall notice. Users should stop using these specific catheters in MR environments and refer to the updated labeling provided by the manufacturer.
The recalled product
- Product
- Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 28,752
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)
- Catog No. 110-4B
- Lot No.: 305000222640
- 305000223280
- 305000223866
- 305000223867
- 305000224353
- 305000225045
- 305000225632
- 305000225633
- 305000226127
- 305000226836
- 305000226844
- 305000227128
- 305000228521
- 305000228522
- 305000228971
- 305000229328
- 305000229329
- 305000229825
- 305000229826
Distribution
Distribution scope not specified by the agency.
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