FDA Enforcement
Class II
Terminated
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
Recall: Z-2905-2016
·
Reported October 12, 2016
Enforcement
- Recall Number
- Z-2905-2016
- Event ID
- 75065
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 12, 2016
- Initiation Date
- August 23, 2016
- Classification Date
- September 30, 2016
- Termination Date
- March 29, 2017
- Address
- 311 Enterprise Dr, N/A, Plainsboro, NJ, 08536-3344, United States
Description
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
Reason
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Code Info
Catalog Number VC-1, Lot #0195451 with expiry 05/2019
Distribution
Nationwide Distribution to KS only
Quantity
10