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U.S. Department of Health and Human Services

Class 3 Device Recall ANGIODYNAMICS 4F Stiffened MicroIntroducer

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  Class 3 Device Recall ANGIODYNAMICS 4F Stiffened MicroIntroducer see related information
Date Initiated by Firm September 28, 2016
Create Date December 16, 2016
Recall Status1 Terminated 3 on June 18, 2018
Recall Number Z-0778-2017
Recall Event ID 75420
510(K)Number K051655  
Product Classification Introducer, catheter - Product Code DYB
Product ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103
Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
Code Information Batch/Lot: 1) 5034283
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information Contact Gary Barrett
508-658-7940
Manufacturer Reason
for Recall		 Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
FDA Determined
Cause 2		 Component design/selection
Action Angiiodynamics sent an Urgent Voluntary Medical Device Recall letter dated September 28, 2016, to all affected customers. Recall notifications were delivered by Federal Express. Customers were instructed to segregate and return all affected devices to AngioDynamics and to complete and return the Reply Verification Tracking Form, provided in the recall notification by fax to 1-800-782-1357. Customers were encouraged to forward a copy of the recall notification to all sites to which have distributed affected product. If affected product is located in your institution, 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) to obtain a replacement or credit for your returned product. Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form via to recall@angiodynamics.com. Customers with questions should contact customer service at 1-800-772-6446.
Quantity in Commerce 4 boxes
Distribution Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX
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 = DYB and Original Applicant = ANGIODYNAMICS, INC.
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