FDA Device recall Z-0851-2024
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
- FDA Device
- Class I
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class I recall of Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777 by Cardinal Health 200, citing cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0851-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-12-28 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
Reason
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Identifiers
| code_info | UDI/DI 50192253034538 (Case), 20192253034537 (Box), 10192253034530 (Each), Lot Numbers: 221201, 221202, 221203, 230201, 230202, 230203, 230204, 230205, 230601 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0851-2024%22
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