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U.S. Department of Health and Human Services

Class 2 Device Recall Morpheus Smart PICC

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  Class 2 Device Recall Morpheus Smart PICC see related information
Date Initiated by Firm February 06, 2012
Date Posted February 21, 2012
Recall Status1 Terminated 3 on February 10, 2016
Recall Number Z-1068-2012
Recall Event ID 61124
510(K)Number K093406  
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
Product 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.
Code Information Lot 549559
Recalling Firm/
Manufacturer		 Angiodynamics Worldwide Headquarters
14 Plaza Drive
Latham NY 12110-3421
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
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 and Original Applicant = ANGIODYNAMICS, INC.
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