Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device
FDA device recall Z-1984-2012 · posted 2012-07-10 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp
- Reason for recall
- 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".
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- JXG
- Quantity affected
- 39 units
- Distribution
- International Only Distribution, including the countries of Thailand and Japan.
- Date initiated
- 2012-04-04
- Date posted
- 2012-07-10
- Date terminated
- 2012-08-02
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VALVE, STANDARD MODEL PUDENZE FLUSHING (K760501) | Heyer Schulte Corp. | 1976-08-30 |