AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 4F Single Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contai
FDA device recall Z-1069-2012 · posted 2012-02-21 · Terminated
Recall details
- Recalling firm
- Angiodynamics Worldwide Headquarters
- Reason for recall
- The Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire.
- Action taken
- AngioDynamics sent an "URGENT-MEDICAL DEVICE RECALL" letter dated February 2, 2012 to the single customer. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs the customer to identify and segregate the affected product. A Morpheus Smart PICC Recall Reply Form was enclosed for the customer to complete and return via fax to 518-798-1360. Contact AngioDynamics Customer Service at 1-800-772-6446 for questions regarding this notice.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 25 units
- Distribution
- Distributed to one customer in Wisconsin.
- Date initiated
- 2012-02-06
- Date posted
- 2012-02-21
- Date terminated
- 2016-02-10
- 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 |
|---|---|---|
| MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 (K093406) | AngioDynamics, Inc. | 2010-03-25 |