FDA Device recall Z-2996-2024
Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815 by Medline Industries Northfield, citing 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 m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2996-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-08 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | n/a |
Product
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
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.
Identifiers
| code_info | CVI4815, Lot Number 2022031150; CVI4815, Lot Number 2022042250; CVI4815, Lot Number 2022121390; CVI5045, Lot Number…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2996-2024%22
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