FDA Enforcement
Class II
Ongoing
Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Number DYNJ84657
Recall: Z-3039-2024
·
Reported September 18, 2024
Enforcement
- Recall Number
- Z-3039-2024
- Event ID
- 94583
- 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
- September 18, 2024
- Initiation Date
- April 8, 2024
- Classification Date
- September 6, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Number DYNJ84657
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
DYK1002355X3, Lot Number 21JFA080; DYNJ84657, Lot Number 23GBD229
Distribution
Worldwide distribution.