Z-0467-2012

MORPHEUS CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF 1200923, STERILE...

Name: Z-0467-2012 MORPHEUS CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF 1200923, STERILE...
Creator: Angiodynamics Worldwide Headquarters
Published: 2011-12-05
License: https://open.fda.gov/license/

Angiodynamics Worldwide Headquarters / initiated 2011-12-05 / Terminated

FDA source

Angiodynamics Worldwide Headquarters began a recall of MORPHEUS CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF 1200923, STERILE, AngioDynamics Queensbury, NY 12804 USA --- COMMON/USUAL... on 2011-12-05. The reason FDA records is "AngioDynamics distributed the affected PICC catheters that were beyond their expiration date". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0467-2012
Status: Terminated
Initiated: 2011-12-05
Posted: 2012-01-11
Terminated: 2012-09-27
Recalling firm: Angiodynamics Worldwide Headquarters
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.
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: AngioDynamics distributed the affected PICC catheters that were beyond their expiration date.
FDA root cause: Incorrect or no 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.
Product codes and lots: Lot Number 974842 (exp. 10/2009)

Product code LJS

K030415Class IIAngiodynamics, Inc. Morpheus Picc and Procedure KitAngioDynamics, Inc. / cleared 2003-04-30

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)