FDA Device recall Z-0938-2023
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology
- FDA Device
- Class II
- ongoing
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class II recall of HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology by Stradis Healthcare, citing potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0938-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-15 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stradis Healthcare |
| Distribution | US |
Product
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Reason
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Identifiers
| code_info | Assembly Number HCT3548-2, UDI-DI: M752HCT354821, Lot Numbers: 222770947, 221809694, 221938965, 221748547, 221578546, 2…Assembly Number HCT3548-2, UDI-DI: M752HCT354821, Lot Numbers: 222770947, 221809694, 221938965, 221748547, 221578546, 221808445, 221386002, 222859338, 222940522, 221938972 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0938-2023%22
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