Device product
Medline procedural kits labeled as: 1) CAROTID ENDARTERECTOMY PK, Pack Number DYNJ85516; 2) PICC INSERTION TRAY W/O CATH, Pack Number PICCNC0004; 3) VASCATH INSERTION PACK, Pack Number, CVI4825
Z-2745-2024
Product summary
- Event
- Event 94581
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-2745-2024
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: DYNJ85516, Lot Number 23JBI659 ; DYNJ85516, Lot Number 23LBE170 ; DYNJ85516, Lot Number 23LBR472 ; PICCNC0004 , Lot Number 23JMG079 ; CVI4825, Lot Number 22FLA595 ; CVI4825, Lot Number 22JLA721 ; CVI4825, Lot Number 22JLB203 ; CVI4825, Lot Number 22KLA852
Distribution pattern: Worldwide
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.