Z-0912-2012

AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow...

Name: Z-0912-2012 AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow...
Creator: Angiodynamics Worldwide Headquarters
Published: 2012-01-09
License: https://open.fda.gov/license/

Angiodynamics Worldwide Headquarters / initiated 2012-01-09 / Terminated / root cause: manufacturing process

FDA source

Angiodynamics Worldwide Headquarters began a recall of AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog... on 2012-01-09. The reason FDA records is "The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0912-2012
Status: Terminated
Initiated: 2012-01-09
Posted: 2012-01-26
Terminated: 2016-02-05
Recalling firm: Angiodynamics Worldwide Headquarters
Product: AngioDynamics Special Order Morpheus Smart PICC CT 65cm 5F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 4mL/sec --- Injector Pressure Limit --- Catalog No.: 52102638--- Made in the USA --- [Manufacturer symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804 indicated 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: The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: AngioDynamics, Inc. sent an Urgent - Medical Device Recall letter dated January 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and segragate the recalled affected product. Complete the enclosed Morpheus Ct PICC Recall Reply Form and fax it to the attention of the Morpheus CT PICC Recall Coordinator at 518-798-1360. If customers do not have any affected product remaining in their possession they should fill out the attached form noting zero quantity to be returned and fax the form to 518-798-1360. If customers distributed the affected product, they should inform their customers of this recall action immediately and have them return the recalled units to them. For any questions regarding this recall call 1-800-772-6446 or e-mail [email protected].
Quantity in commerce: 145 units
Distribution: Nationwide
Product codes and lots: FG Lot Number: 552388, 553291, 554555, 555166

Product code LJS

K093406Class IIMorpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519AngioDynamics, Inc. / cleared 2010-03-25

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)