RecallRadar

FDA Device recall Z-0147-2024

Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack

On 2023-11-01 the FDA classified a Class I recall of Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack by Cardinal Health 200, citing demonstrated recognition and compatibility issues with syringe infusion pumps.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0147-2024
ClassificationClass I
Statusongoing
Initiated2023-09-20
Published2023-11-01
Last updated2026-09-13 11:56 UTC
CompanyCardinal Health 200
DistributionUS

Product

Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack

Reason

Demonstrated recognition and compatibility issues with syringe infusion pumps.

Identifiers

code_infoProduct Code: 1181200777T; UDI/DI: 10192253025811 - each, 20192253025818 - box, 50192253025819 - case; Lot Numbers: 221101, 221102, 221103, 221104

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-0147-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.