—#207667

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

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K131641
Affected lot / code info: UDI-DI: 20884521012230 Lot Code: 330737X

Why it was recalled

Quarantined product was inadvertently distributed

Root cause (FDA determination)

Component change control

Action the firm took

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.

Recalling firm

Firm: Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Distribution

Distribution pattern: US Nationwide distribution in the state of NJ.

Timeline

Recall initiated: 2024-04-23
Posted by FDA: 2024-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207667. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.