Device product
Medline Convenience kits labeled as: SCS-LF, DYNJ902314D
Z-3022-2024
Product summary
- Event
- Event 94583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-3022-2024
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: DYNJ902314D, Lot Number 20FDA446 ; DYNJ902314D, Lot Number 20GDA480 ; DYNJ902314D, Lot Number 20IDA880 ; DYNJ902314D, Lot Number 20JDA187 ; DYNJ902314D, Lot Number 21CDA064 ; DYNJ902314D, Lot Number 21EDA709 ; DYNJ902314D, Lot Number 21EDA908 ; DYNJ902314D, Lot Number 21FDA451 ; DYNJ902314D, Lot Number 21FDB959 ; DYNJ902314D, Lot Number 21HDA759 ; DYNJ902314D, Lot Number 21IDC401 ; DYNJ902314D, Lot Number 21KDC395 ; DYNJ902314D, Lot Number 22CDA599 ; DYNJ902314D, Lot Number 22EDB585 ; DYNJ902314D, Lot Number 22IDA541 ; DYNJ902314D, Lot Number 22KDB745 ; DYNJ902314D, Lot Number 23BDA383 ; DYNJ902314D, Lot Number 23DDB444 ; DYNJ902314D, Lot Number 23EDA371
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.