NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. The product is shipped in cases of 5 u
FDA device recall Z-0349-05 · posted 2005-01-08 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- complaints of vessel erosion when using this product
- Action taken
- The recalling firm issued a letter dated 11/23/04 to physicians informing them of the increase in complaints for vessel erosion and one death (at that time). On 12/3/04, the recalling firm issued a press release to alert the medical community of the problem and the need to return the device. The recalling firm issued a recall letter dated 12/7/04, to the Director of Purchasing, informing them of the adverse events associated with the use of the product and the need to return all of their inventory.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 36340 units
- Distribution
- The products were shipped to through specialty dealers/distributors to medical facilities nationwide. The product is also sold to government accounts and sales representatives. The product is also sol
- Date initiated
- 2004-11-24
- Date posted
- 2005-01-08
- Date terminated
- 2006-06-14
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NEO-PICC (K970434) | Klein-Baker Medical, Inc. | 1997-04-01 |