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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