Date Initiated by Firm | August 06, 2014 |
Date Posted | August 18, 2014 |
Recall Status1 |
Terminated 3 on March 27, 2017 |
Recall Number | Z-2262-2014 |
Recall Event ID |
68980 |
510(K)Number | K905447 K951602 K961763 |
Product Classification |
Catheter, continuous flush - Product Code KRA
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Product | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804 |
Code Information |
Lot 4762513 (exp. date 31-May-17) |
Recalling Firm/ Manufacturer |
Angiodynamics, Inc. 603 Queensbury Ave Queensbury NY 12804-7619
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For Additional Information Contact | Michael Duerr 518-742-4571 |
Manufacturer Reason for Recall | AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long). |
FDA Determined Cause 2 | Component design/selection |
Action | AngioDynamics sent an URGENT MEDICAL DEVICE RECALL Letter dated August 6, 2014, to all affected customers via Federal Express. Consignees were instructed to segregate and return all affected devices to AngioDynamics,
Inc. and complete and return the Reply Verification Tracking Form, provided in the recall notification. Those customers with the affected product were also instructed to call AngioDynamics Customer Service at 1-800-772-6446.
For questions regarding this recall call 718-742-4571. |
Quantity in Commerce | Domestic: 36 units |
Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland. |
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 = KRA 510(K)s with Product Code = KRA
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