Class 2 Device Recall AngioDynamics Morpheus Smart PICC CT

• Date Initiated by Firm: January 09, 2012
• Date Posted: January 26, 2012
• Recall Status: Terminated on February 05, 2016
• Recall Number: Z-0886-2012
• Recall Event ID: 60909
• 510(K)Number: K093406
• Product Classification: Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
• Product: AngioDynamics Morpheus Smart PICC CT 65cm 6F Dual Lumen --- Max CT Flow Rate: 6mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102806 --- Made in the USA --- [Manufacturing symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY USA 12804 indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
• Code Information: FG Lot Number: 553486
• Recalling Firm/ Manufacturer: Angiodynamics Worldwide Headquarters; 14 Plaza Drive; Latham NY 12110-3421
• For Additional Information Contact: David Greer; 518-795-1676
• Manufacturer 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.
• FDA Determined 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 customerservice@angiodynamics.com.
• Quantity in Commerce: 100 units
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LJS