Z-3007-2024 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: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2) DIALYSIS INSERTION BUNDLE-ADD CATHETER, Pack Number CVI4835; 3) DIALYSIS TAKE OFF KIT , Pack Number DT18185; 4) DIALYSIS TRAY , Pack Number DT22005; 5) PRE POST DIALYSIS, Pack Number DYNDC3274; 6) MYELOGRAM TRAY, Pack Number DYNDH1531; 7) ADULT LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4301; 8) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 9) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS8100; 10) LUMBAR PUNCTURE TRAY, Pack Number PT215; 11) FINE LACERATION KIT, Pack Number SUT19360
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
CVI4830A, Lot Number 2022072850; CVI4835, Lot Number 2022061350; CVI4835, Lot Number 2022072850; CVI4835, Lot Number 2023111490; CVI4835, Lot Number 2023112790; DT18185, Lot Number 23EBS508 ; DT18185, Lot Number 23FBU960 ; DT18185, Lot Number 23HBQ339 ; DT22005, Lot Number 21JBI227 ; DYNDC3274, Lot Number 2022111490; DYNDC3274, Lot Number 2023101190; DYNDC3274, Lot Number 2023112790; DYNDH1531, Lot Number 2022111490; DYNJTS4301, Lot Number 2022061350; DYNJTS4301, Lot Number 2022061350; DYNJTS4306, Lot Number 2022061350; DYNJTS8100, Lot Number 2022061350; PT215, Lot Number 2022061350; SUT19360, Lot Number 2022111490