FDA Device recall Z-0847-2024
Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
- FDA Device
- Class I
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class I recall of Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE by Cardinal Health 200, citing the listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0847-2024 |
| 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, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
Reason
The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps.
Identifiers
| code_info | UDI/DI 26971564466220 (Case), 16971564466223 (Box), 06971564466226 (Each), Lot Numbers: 230503 and 230701 |
|---|
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-0847-2024%22
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