Z-2996-2024 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) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack Number CVI5045; 3) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 4) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 5) BIOPSY TRAY, Pack Number DYNDH1693A; 6) PACK,ULTRASOUND, Pack Number DYNDL1461; 7) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 8) ARTHROGRAM TRAY, Pack Number SPEC0143A; 9) PD CATH KIT, Pack Number UVT1205
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
CVI4815, Lot Number 2022031150; CVI4815, Lot Number 2022042250; CVI4815, Lot Number 2022121390; CVI5045, Lot Number 2023101290; DYNDA2906, Lot Number 2022042250; DYNDH1319, Lot Number 2022031150; DYNDH1693A, Lot Number 2022042250; DYNDL1461, Lot Number 2022042250; DYNJTS4306, Lot Number 2022042250; SPEC0143A, Lot Number 2022042250; UVT1205, Lot Number 2022072650; UVT1205, Lot Number 2022081650