Integra Recalls Mislabeled Bactiseal Ventricular Catheters for Hydrocephalus Treatment
Integra LifeSciences is recalling 85 units of Bactiseal Ventricular Catheters that were mislabeled as Endoscopic Ventricular Catheters. The error involves swapped product labels for part numbers 823073 and 823087.
What this means for you
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, which typically involves a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error, which fits the 'Moderate' criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Integra LifeSciences Corp. is recalling 85 units of Bactiseal Ventricular Catheters with Bactiseal Shunt System (Part Number 823073). These devices are used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF). The specific lot number is 4178253, with an expiration date of November 2019.
The recall was initiated because the product was mislabeled. Specifically, the Bactiseal Ventricular Catheter (823073) was mislabeled as the Bactiseal Endoscopic Ventricular Catheter (823087), and vice versa. This labeling error could lead to the use of the wrong device type for a specific procedure.
The affected units were distributed nationwide in the United States. Healthcare providers and facilities that received these devices should stop using them and contact the manufacturer for instructions on how to return or dispose of the product.
The recalled product
- Product
- Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 85
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)
- Lot Number: 4178253 Exp. Date: November 2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Integra LifeSciences Corp. 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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