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U.S. Department of Health and Human Services

Class 3 Device Recall MORPHEUS PICC

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  Class 3 Device Recall MORPHEUS PICC see related information
Date Initiated by Firm December 05, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on September 27, 2012
Recall Number Z-0467-2012
Recall Event ID 60590
510(K)Number K030415  
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
Product MORPHEUS CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF 1200923, STERILE, AngioDynamics Queensbury, NY 12804 USA --- COMMON/USUAL NAME: Percutaneous, implanted, long-term intravascular catheter; CLASSIFICATION NAME: Percutaneous, implanted, long-term intravascular catheter; Device Listing # D095274.

PICC Catheters are utilized for Short or Long Term peripheral access to the Central Venous system for intravenous therapy and power injections of contrast media.
Code Information Lot Number 974842 (exp. 10/2009)
Recalling Firm/
Manufacturer		 Angiodynamics Worldwide Headquarters
14 Plaza Drive
Latham NY 12110-3421
For Additional Information Contact David A. Greer
518-795-1676
Manufacturer Reason
for Recall		 AngioDynamics distributed the affected PICC catheters that were beyond their expiration date.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action AngioDynamics sent an "URGENT-MEDICAL DEVICE RECALL" letter dated December 2, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. A Recall Reply Form was attached to the letter for customers to complete and return to the firm via fax at 518-798-1360. Contact your local sales representative or AngioDynamics Customer Service at 800-772-6446 for questions regarding this notice.
Quantity in Commerce 16 units domestically
Distribution Nationwide Distribution-including the states of Florida, Georgia, Montana, and Tennessee.
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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