Oscor, Inc. Recall 87562
Description: AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Oscor, Inc. Recall 87562 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1329-2021 |
| Event ID | 87562 |
| Event Description | AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of New York. |
| Quantity | 500 devices |
| Recall Reason | Potential for open seal on sterile product |
| Device Classification | 20210407 |
| Device Code Info | GUDID: 25051684026298; Lot Number DP-11759 |
| Center Classification Date | 20210401 |
| Recall Initiation Date | 20210310 |
| Recalling Firm | Oscor, Inc. |
| Initial Notification | Telephone |
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