Monoject recallZ-2039-2024 · Mckesson Medical-Surgical Inc. Corporate Office · initiated Apr 23, 2024
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mckesson Medical-Surgical Inc. Corporate Office or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Quarantined product was inadvertently distributed
FDA root cause category: Component change control
What the company is doing
McKesson notified one consignee by telephone on 4/11/24. Spoke with Nurse and confirmed product was received and confirmed that four (4) boxes were picked up by a McKesson Driver and one (1) box was used.
Recall details
- Recall number
- Z-2039-2024
- Status
- Completed
- Initiated by the company
- Apr 23, 2024
- Posted by the FDA
- Jun 7, 2024
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Quantity
- 5 Boxes (20 per box, 100 eaches)
- Product code
- FMF
- FDA submissions
- K131641
- Distribution
- US Nationwide distribution in the state of NJ.
Product description
Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog Number: 1159851 Cardinal Catalog Number: 8881560125
Code information (models, lots, serial numbers)
UDI-DI: 20884521012230 Lot Code: 330737X
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Monoject 8881560125Cardinal Health, Inc. · Syringe, piston1 recall17 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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