FDA Enforcement
Class II
Ongoing
General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
Recall: Z-3154-2024
·
Reported September 25, 2024
Enforcement
- Recall Number
- Z-3154-2024
- Event ID
- 95223
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cypress Medical Products LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 25, 2024
- Initiation Date
- August 6, 2024
- Classification Date
- September 16, 2024
- Address
- 9954 Mayland Dr, Richmond, VA, 23233-1464, United States
Description
General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
Reason
The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.
Code Info
UDI-DI: 20612479170302;
Distribution
US Nationwide distribution in the states of CA, NV, NY.
Quantity
3 Boxes (25 per box, 75 total units)