Device product
Medline Convenience kits, labeled as: GAMMA NAIL CDS-LF , Pack Number CDS983505K
Z-3057-2024
Product summary
- Event
- Event 94583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-3057-2024
Official wording
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 information: CDS983505K , Lot Number 23HBC802 ; CDS983505K , Lot Number 23JBQ026 ; CDS983505K , Lot Number 23LBQ345 ; CDS983505K , Lot Number 24ABI223
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
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.