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U.S. Department of Health and Human Services

Class 2 Device Recall Vortex MP Port

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 Class 2 Device Recall Vortex MP Portsee related information
Date Initiated by FirmSeptember 20, 2022
Date PostedOctober 25, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0132-2023
Recall Event ID 90924
510(K)NumberK033473 
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
ProductVortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling UPN: H787MPP5SAT0 Catalog Number: MP-P5SAT
Code Information UDI-DI: 15051684018357 Lot Number: 5751582 Exp. Date: 31-Aug-2025
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information ContactSAME
518-798-1215
Manufacturer Reason
for Recall		Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of the implantable port, failure to follow the Instructions for Use may result in patient injury.
FDA Determined
Cause 2		Under Investigation by firm
ActionAngiodynamics issued Urgent Medical Device Correction Letter on 09-20-2022 via Federal Express. Letter states reason for recall, health risk and action to take: Identify if any of the affected product is in your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). " Place the supplied Instructions for Use with each of the affected product(s) in your possession " Forward a copy of this recall notification and Instructions for Use to all sites to which you have distributed affected product. If you have any questions regarding the corrective action as stated above, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time). " If additional Instructions for Use are required, please note the quantity needed on the enclosed Reply Verification Tracking Form. " Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product affected by this correction). Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com Fax Reply Verification Tracking Form: Attn: Vortex MP Correction Coordinator Fax number 1-855-273-0519
Quantity in Commerce11 units
DistributionUS Nationwide distribution in the states of AZ, CA, DC, IN, PA.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LJT
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