FDA Enforcement
Class II
Ongoing
Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
Recall: Z-2515-2024
·
Reported August 14, 2024
Enforcement
- Recall Number
- Z-2515-2024
- Event ID
- 94584
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- August 14, 2024
- Initiation Date
- April 8, 2024
- Classification Date
- August 7, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
Reason
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Code Info
Lot Number 2019072590
Distribution
Worldwide distribution.