Date Initiated by Firm |
March 10, 2021 |
Create Date |
April 01, 2021 |
Recall Status1 |
Terminated 3 on August 08, 2023 |
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
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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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