| | Class 3 Recall
MORPHEUS PICC |  |
| Date Posted |
January 11, 2012 |
| Recall Number |
Z-0467-2012 |
| Product |
MORPHEUS CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF 1200923, STERILE, AngioDynamics Queensbury, NY 12804 USA --- COMMON/USUAL NAME: Percutaneous, implanted, long-term intravascular catheter; CLASSIFICATION NAME: Percutaneous, implanted, long-term intravascular catheter; Device Listing # D095274.
PICC Catheters are utilized for Short or Long Term peripheral access to the Central Venous system for intravenous therapy and power injections of contrast media. |
| Code Information |
Lot Number 974842 (exp. 10/2009)
|
Recalling Firm/
Manufacturer |
Angiodynamics Worldwide Headquarters
14 Plaza Drive
Latham, New York 12110-3421 |
| For Additional Information Contact |
David A. Greer
518-795-1676
|
Reason for
Recall |
AngioDynamics distributed the affected PICC catheters that were beyond their expiration date.
|
| Action |
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. |
| Quantity in Commerce |
16 units domestically |
| Distribution |
Nationwide Distribution-including the states of Florida, Georgia, Montana, and Tennessee. |
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