Stradis Healthcare Recall 91350
Description: HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
Stradis Healthcare Recall 91350 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0941-2023 |
| Event ID | 91350 |
| Event Description | HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. |
| Quantity | 200 units |
| Recall Reason | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
| Device Classification | 20230118 |
| Device Code Info | Assembly Number HCT8428CP-2, UDI-DI: M752HCT8428CP20, Lot Number: 222218373 |
| Center Classification Date | 20230111 |
| Recall Initiation Date | 20221215 |
| Recalling Firm | Stradis Healthcare |
| Initial Notification | |
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