| Date Initiated by Firm | December 05, 2011 |
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| Date Posted | January 11, 2012 |
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| Recall Status1 |
Terminated 3 on September 27, 2012 |
| Recall Number | Z-0467-2012 |
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| Recall Event ID |
60590 |
| 510(K)Number | K030415 |
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| 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. |
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| Code Information |
Lot Number 974842 (exp. 10/2009) |
| FEI Number |
3008319439
|
Recalling Firm/
Manufacturer |
Angiodynamics Worldwide Headquarters
14 Plaza Drive
Latham NY 12110-3421
|
| For Additional Information Contact | David A. Greer
518-795-1676 |
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Manufacturer Reason
for Recall | AngioDynamics distributed the affected PICC catheters that were beyond their expiration date. |
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FDA Determined
Cause 2 | Incorrect or no expiration date |
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| 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. |
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| Quantity in Commerce | 16 units domestically |
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| Distribution | Nationwide Distribution-including the states of Florida, Georgia, Montana, and Tennessee. |
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| 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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