The Recall Desk
HighFDA (Devices)·Z-2039-2024·Announced 2024-06-19

Coviden Monoject 60ml Syringes Recalled for Inadvertent Distribution

Coviden Monoject 60ml Luer-Lock syringes were inadvertently distributed despite being quarantined. Mckesson Medical-Surgical is recalling approximately 100 units (lot 330737X) distributed in the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II medical device recall involves a quarantined product inadvertently distributed without reported injuries. Per the rubric, uninjured risk-of-harm products score 3 (High); the Class II classification without hospitalization reports precludes a higher score.

Plain-English summary

Mckesson Medical-Surgical Inc. is recalling Coviden Monoject 60ml Syringe with Luer-Lock Tip (catalog numbers 1159851 and 8881560125). The recall covers lot 330737X, containing 100 units (5 boxes of 20 units each). The syringes were placed under quarantine but were inadvertently distributed in violation of that quarantine status.

The affected syringes were distributed in the United States. Anyone who may have received this product should check the lot number and contact Mckesson Medical-Surgical for further guidance regarding returns or replacements.

The recalled product

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
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 20884521012230 Lot Code: 330737X

Distribution

Distributed nationwide across the United States.