AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 5F Dual Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm (0.018in.) x 130cm --- Catalog No. [REF] 52110901 --- [Mfg symbol] AngioDynamics, Inc., 603 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-1068-2012 · Posted 2012-02-21
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Recalling FirmAngiodynamics Worldwide Headquarters
Recall StatusTerminated
Product CodeLJS
Date Initiated2012-02-06
Date Terminated2016-02-10
Product Quantity25 units
Reason for Recall
The Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire.
Firm Action
AngioDynamics sent an "URGENT-MEDICAL DEVICE RECALL" letter dated February 2, 2012 to the single customer. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs the customer to identify and segregate the affected product. A Morpheus Smart PICC Recall Reply Form was enclosed for the customer to complete and return via fax to 518-798-1360. Contact AngioDynamics Customer Service at 1-800-772-6446 for questions regarding this notice.
Root Cause
Labeling mix-ups
Distribution Pattern
Distributed to one customer in Wisconsin.
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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