Date Initiated by Firm | February 06, 2012 |
Date Posted | February 21, 2012 |
Recall Status1 |
Terminated 3 on February 10, 2016 |
Recall Number | Z-1069-2012 |
Recall Event ID |
61124 |
510(K)Number | K093406 |
Product Classification |
Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
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Product | AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 4F Single Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm (0.018in.) x 130cm --- Catalog No. [REF] 52110902 --- [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. |
Code Information |
Lot 549560 |
Recalling Firm/ Manufacturer |
Angiodynamics Worldwide Headquarters 14 Plaza Drive Latham NY 12110-3421
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Manufacturer Reason for Recall | The Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire. |
FDA Determined Cause 2 | Labeling mix-ups |
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. |
Quantity in Commerce | 25 units |
Distribution | Distributed to one customer in Wisconsin. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LJS
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