Recall Z-1984-2012 ยท JXG Shunt, Central Nervous System And Components
Integra LifeSciences Corp
Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain.
| Date | Jul 10, 2012 (initiated Apr 4, 2012) |
| Status | Terminated |
| Reason | The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the device. The incorrect label reads: "Model: 12 mm-Medium Pressure" instead of "Model: 16 mm-Low Pressure". |
| Root cause | Labeling Change Control |
| Action | The firm initiated a voluntary recall by notifying the two consignees initially via email and then with an "URGENT: MEDICAL DEVICE RECALL" dated April 5th or 9th, 2012. The letter informed them of the labeling error and provided instructions regarding affected product. The International Customer Service number was provided 609-936-5400. |
| Quantity | 39 units |
| Distribution | International Only Distribution, including the countries of Thailand and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K760501 | VALVE, STANDARD MODEL PUDENZE FLUSHING Heyer Schulte Corp., Aug 30, 1976 |