FDA Device recall Z-2195-2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510
- FDA Device
- Class II
- ongoing
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510 by Medline Industries Northfield, citing probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2195-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-18 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;
Reason
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Identifiers
| code_info | All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CVI4510, UDI/DI (…All lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CVI4510, UDI/DI (EA) 10653160321194, UDI/DI (CS) 00653160321197; b) Model Number STCVC01145B, UDI/DI (EA) 10653160351924, UDI/DI (CS) 00653160351927; c) Model Number STCVC2000, UDI/DI (EA) 10653160336792, UDI/DI (CS) 00653160336795 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2195-2023%22
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