Z-2745-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2024
- Initiation Date
- April 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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
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
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