Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA Percutaneous Cathet
FDA device recall Z-2313-2009 · posted 2009-09-24 · Terminated
Recall details
- Recalling firm
- Penumbra Inc.
- Reason for recall
- Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery'
- Action taken
- Firm initiated its recall on June 30, 2009. Consignees notified on July 6 and 7, with follow up contact on July 7, 2009. Contact Penumbra Inc. at 1.510.618.3223, if there are any questions.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 37 units
- Distribution
- CA, FL, NC, MI, MO, VA, AZ, CT, IA, NY, and CO, Foreign: Germany and Australia.
- Date initiated
- 2009-07-01
- Date posted
- 2009-09-24
- Date terminated
- 2010-11-30
- Location
- Alameda, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F (K070970) | Penumbra, Inc. | 2007-08-17 |