AngioDynamics Morpheus Smart PICC CT 55cm 5F Dual Lumen with REVERSE TAPER --- Max CT Flow Rate: 5mL/SEC --- Injector Pressure Limit: 300 PSI --- Catalog No. [REF] 12102616 --- 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.
FDA Recall Z-0883-2012 · Posted 2012-01-26
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Recalling FirmAngiodynamics Worldwide Headquarters
Recall StatusTerminated
Product CodeLJS
Date Initiated2012-01-09
Date Terminated2016-02-05
Product Quantity5 units
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.
Firm 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].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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