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Completed

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 Recall Z-2039-2024 · Posted 2024-06-07

Recall StatusCompleted
Product CodeFMF
Date Initiated2024-04-23
Product Quantity5 Boxes (20 per box, 100 eaches)

Reason for Recall

Quarantined product was inadvertently distributed

Firm 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.

Root Cause

Component change control

Distribution Pattern

US Nationwide distribution in the state of NJ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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