Integra Pudenz Flushing Valve Recalled for Incorrect Labeling
Integra LifeSciences is recalling 39 Pudenz Flushing Valves because the pouch labels list the wrong model and closing pressure.
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 involves a labeling error regarding device specifications. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Integra LifeSciences Corp is recalling 39 units of the Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. The device is used to treat hydrocephalic patients by shunting cerebrospinal fluid from the ventricles of the brain.
The recall was initiated because the pouch label for catalog NL850-1330 indicates an incorrect model and closing pressure. The label incorrectly reads "Model: 12 mm-Medium Pressure" instead of the correct "Model: 16 mm-Low Pressure." The affected units have lot codes 1115647, 1115939, and 1120413.
The distribution was international only, including Thailand and Japan. No specific instructions for consumers are provided in the source text, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain.
- Manufacturer
- Integra LifeSciences Corp
- Category
- Medical Device — Neurological
- Hazard
- Affected units
- 39
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 (3)
- 1115647
- 1115939
- 1120413
Distribution
Distribution scope not specified by the agency.
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