Stradis Medical, LLC dba Stradis Healthcare Recall 91124
Description: HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
Stradis Medical, LLC dba Stradis Healthcare Recall 91124 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0522-2023 |
| Event ID | 91124 |
| Event Description | HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891 |
| Product Type | Devices |
| Distribution | US nationwide distribution, and Canada. |
| Quantity | 144 units |
| Recall Reason | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. |
| Device Classification | 20221221 |
| Device Code Info | UDI/DI (case) H65857028911, UDI/DI (kit)M75257028910, Serial/Lot Numbers: 22252491813 |
| Center Classification Date | 20221214 |
| Recall Initiation Date | 20221102 |
| Recalling Firm | Stradis Medical, LLC dba Stradis Healthcare |
| Initial Notification | |
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