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U.S. Department of Health and Human Services

Class 2 Device Recall AngioDynamics SafeSheath ULTRALITE

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  Class 2 Device Recall AngioDynamics SafeSheath ULTRALITE see related information
Date Initiated by Firm March 10, 2021
Create Date April 01, 2021
Recall Status1 Completed
Recall Number Z-1329-2021
Recall Event ID 87562
Product Classification Introducer, catheter - Product Code DYB
Product AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Code Information GUDID: 25051684026298; Lot Number DP-11759
Recalling Firm/
Manufacturer
Oscor, Inc.
3816 Desoto Blvd
Palm Harbor FL 34683-1618
For Additional Information Contact Bethania Tavarez
727-937-2511 Ext. 133
Manufacturer Reason
for Recall
Potential for open seal on sterile product
FDA Determined
Cause 2
Under Investigation by firm
Action The firm notified their sole consignee of the recall by letter on 03/23/2021 as a written follow-up communication held on 03/10/2021 which requested the return of the recalled product.
Quantity in Commerce 500 devices
Distribution US Nationwide distribution in the state of New York.
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.
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