MORPHEUS CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF 1200923, STERILE, AngioDynamics Queensb
FDA device recall Z-0467-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Angiodynamics Worldwide Headquarters
- Reason for recall
- AngioDynamics distributed the affected PICC catheters that were beyond their expiration date.
- Action taken
- AngioDynamics sent an "URGENT-MEDICAL DEVICE RECALL" letter dated December 2, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. A Recall Reply Form was attached to the letter for customers to complete and return to the firm via fax at 518-798-1360. Contact your local sales representative or AngioDynamics Customer Service at 800-772-6446 for questions regarding this notice.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 16 units domestically
- Distribution
- Nationwide Distribution-including the states of Florida, Georgia, Montana, and Tennessee.
- Date initiated
- 2011-12-05
- Date posted
- 2012-01-11
- Date terminated
- 2012-09-27
- Location
- Latham, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT (K030415) | AngioDynamics, Inc. | 2003-04-30 |