Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems
Recall
- Recall Number
- Z-2909-2016
- Event Number
- 75065
- Firm
- Integra LifeSciences Corp.
- FEI Number
- 3003418325
- Product Code
- JXG
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- August 23, 2016
- Terminated
- March 29, 2017
- Address
- 311 Enterprise Dr, Plainsboro, NJ, 08536-3344
Description
Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pouch and tertiary packaged in to Tyvek pouch. Sealed pouches are packaged in a cardboard box. F8 35cm Silicone Elastomer Ventricular Catheter for use with CSF external drainage systems
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Integra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.
Nationwide Distribution to KS only
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