Drug recall
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
FDA recall event 91350 · Class II · Stradis Healthcare
Key facts
| Event ID | 91350 |
|---|---|
| Recall numbers | Z-0931-2023, Z-0932-2023, Z-0933-2023, Z-0934-2023, Z-0935-2023, Z-0936-2023, Z-0937-2023, Z-0938-2023, Z-0939-2023, Z-0940-2023, Z-0941-2023, Z-0942-2023 and 6 more |
| Recalling firm | Stradis Healthcare |
| Product type | Devices |
| Products | HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology., HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology., HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology., HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology., HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology and 13 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
| Initiation date | Dec 15, 2022 |
| Report date | Jan 18, 2023 |
| City | Waukegan |
| State | IL |
| Country | United States |
| FEI number | 1450943 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: