Recall Z-1047-201 ยท JXG Shunt, Central Nervous System And Components
Integra Neurosciences PR, Inc.
"***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD, Total Length: 8"***Plainsboro, NJ***" Stainless steel stylet for ventricular catheter
| Date | Feb 16, 2012 (initiated Nov 28, 2011) |
| Status | Terminated |
| Reason | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. |
| Root cause | Labeling mix-ups |
| Action | Integra sent an Urgent Product Recall Notification letter dated November 28, 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fill out and sign the attached Recall Acknowledgement Form noting the part numbers, lot numbers and quantity of the affected product in their inventory. Customers were asked to contact Integra LifeSciences Corporation International Customers Service at 609-936-5400 to arrange for Returns. If customers do not have any of the affected product in their inventory they are required to complete |
| Quantity | 241 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Austria, Canada, Italy, Australia |
| FDA record | Open on fda.gov |