FDAFDA · Food and drugs·Recall number Z-2996-2024
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
Published September 18, 2024 · Recall initiated: April 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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