Recall Z-2905-2016 ยท JXG Shunt, Central Nervous System And Components
Integra LifeSciences Corp.
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
| Date | Aug 23, 2016 |
| Status | Terminated |
| Reason | During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product. |
| Root cause | Process control |
| Action | 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 a |
| Quantity | 10 |
| Distribution | Nationwide Distribution to KS only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033698 | CONTOUR-FLEX VALVE AND SHUNT SYSTEM Integra Neurosciences Implants S.A., Dec 17, 2003 |