AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
This recall has been terminated (originally issued March 10, 2021).
- Company
- Oscor, Inc.
- Recall Initiated
- March 10, 2021
- Terminated
- August 8, 2023
- Recall Number
- Z-1329-2021
- Quantity
- 500 devices
- Firm Location
- Palm Harbor, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for open seal on sterile product
Distribution
US Nationwide distribution in the state of New York.
Lot / Code Info
GUDID: 25051684026298; Lot Number DP-11759
Root Cause
Under Investigation by firm
Action Taken
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.
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