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.
Recall
- Recall Number
- Z-0467-2012
- Event Number
- 60590
- Firm
- Angiodynamics Worldwide Headquarters
- FEI Number
- 3008319439
- Product Code
- LJS
- Status
- Terminated
- Root Cause
- Incorrect or no expiration date
- Initiated
- December 5, 2011
- Posted
- January 11, 2012
- Terminated
- September 27, 2012
- Address
- 14 Plaza Drive, Latham, NY, 12110-3421
Description
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.
AngioDynamics distributed the affected PICC catheters that were beyond their expiration date.
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.
Nationwide Distribution-including the states of Florida, Georgia, Montana, and Tennessee.
16 units domestically