RecallRadar

FDA Device recall Z-0149-2024

Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack

On 2023-11-01 the FDA classified a Class I recall of Monoject" 35 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-0149-2024
ClassificationClass I
Statusongoing
Initiated2023-09-20
Published2023-11-01
Last updated2026-09-13 11:56 UTC
CompanyCardinal Health 200
DistributionUS

Product

Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack

Reason

Demonstrated recognition and compatibility issues with syringe infusion pumps.

Identifiers

code_infoProduct Code: 1183500777; UDI/DI: 10192253034691 - each, 20192253034698 - box, 50192253034699 - case; Lot Numbers: 221201, 230201, 230601, 230602

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-0149-2024%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.