FDA Medical Device Recalls (openFDA)
Mckesson Medical-Surgical Inc. Corporate Office: 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
- Recall number
- Z-2039-2024
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Product
- 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
- Status
- Completed
- Initiated
- 2024-04-23
- Posted
- 2024-06-07
- Terminated
- not on file
- Reason
- Quarantined product was inadvertently distributed
- Root cause
- Component change control
- Action
- 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.
- Quantity
- 5 Boxes (20 per box, 100 eaches)
- Distribution
- US Nationwide distribution in the state of NJ.
- Lot, serial or model codes
- UDI-DI: 20884521012230 Lot Code: 330737X
- 510(k) numbers
- ["K131641"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 3004386693
- Firm city
- Richmond
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28