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U.S. Department of Health and Human Services

Class 2 Device Recall PulseSpray

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  Class 2 Device Recall PulseSpray see related information
Date Initiated by Firm December 18, 2023
Date Posted February 07, 2024
Recall Status1 Open3, Classified
Recall Number Z-1010-2024
Recall Event ID 93744
510(K)Number K163356  
Product Classification Catheter, continuous flush - Product Code KRA
Product PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.

Code Information UDI-DI: 15051684013109, REF: 12500404, Lot: 5795345; UDI-DI: 15051684013215, REF: 12500415, Lot: 5793480; UDI-DI: 15051684013291, REF: 12500423, Lot: 5795344.
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information Contact AngioDynamics Customer Service
800-772-6446
Manufacturer Reason
for Recall		 Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
FDA Determined
Cause 2		 Process control
Action An Urgent Medical Voluntary Medical Device notices dated December 18, 2023 was issued to distributors and end users with instructions to immediately stop using affected product, remove said product from inventory and return to AngioDynamics, Inc. The notice should be forwarded to all site affected product may have been distributed to and recipients are asked to complete and return the Reply Verification Tracking Form. 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.
Quantity in Commerce 7 eaches
Distribution United States (MD, LA & UT), Austria, Canada and Spain.
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 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) Database 510(K)s with Product Code = KRA and Original Applicant = ANGIODYNAMICS, INC.
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