Integra Straight Ventricular Catheter Recalled for Incomplete Packaging Seal
Integra LifeSciences Corp. is recalling 10 units of Straight Ventricular Catheters due to an incomplete packaging seal discovered during final inspection.
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 3/5 (High).
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: The recall involves a sterile medical device with a packaging defect that compromises sterility, representing a risk of harm (infection) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Integra LifeSciences Corp. is recalling 10 units of the Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO. The product is a silicone elastomer ventricular catheter intended for use with hydrocephalus valves and is packaged in a Tyvek pouch and secondary Tyvek pouch, sealed in a cardboard box.
The recall was initiated because an incomplete packaging seal of the sterile product was discovered during final sampling inspection. This defect may compromise the sterility of the device.
The affected lot is identified by Catalog Number VC-1, Lot #0195451, with an expiration date of 05/2019. The distribution was limited to Kansas. Healthcare providers and patients should discontinue use of the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hydrocephalus valves
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 10
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 (2)
- Catalog Number VC-1
- Lot #0195451 with expiry 05/2019
Distribution
Part of a larger recall action
This product is one of 6 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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