Stradis Healthcare Recall 91350
Description: HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Stradis Healthcare Recall 91350 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0938-2023 |
| Event ID | 91350 |
| Event Description | HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. 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 | 112,675 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 HCT3548-2, UDI-DI: M752HCT354821, Lot Numbers: 222770947, 221809694, 221938965, 221748547, 221578546, 221808445, 221386002, 222859338, 222940522, 221938972 |
| Center Classification Date | 20230111 |
| Recall Initiation Date | 20221215 |
| Recalling Firm | Stradis Healthcare |
| Initial Notification | |
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