Z-3057-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2024
- Initiation Date
- April 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K
Reason for Recall
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.
Distribution Pattern
Worldwide distribution.
Code Information
CDS983505K , Lot Number 23HBC802 ; CDS983505K , Lot Number 23JBQ026 ; CDS983505K , Lot Number 23LBQ345 ; CDS983505K , Lot Number 24ABI223