FDA Device recall Z-2193-2023
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A
- 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) RADIAL ARTERIAL LINE KIT, Model Number ART1070A 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-2193-2023 |
| 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) RADIAL ARTERIAL LINE KIT, Model Number ART1070A; b) ARTERIAL LINE START KIT, Model Number ART1160; c) ARTERIAL LINE TRAY W/O CATHETER, Model Number ART1180; d) ARTERIAL LINE INSERTION KIT, Model Number ART775B; e) ARTERIAL LINE KIT W/O CATHETER, Model Number ART890A; f) ARTERIAL BUNDLE NO CATHETER, Model Number ART995; g) ARTERIAL LINE START KIT W/O CATH, Model Number P42453;
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 ART1070A, UDI/DI…all lots within expiry, distributed from Medline between December 2017 May 2023: a) Model Number ART1070A, UDI/DI EA 10653160358329, UDI/DI CS 00653160358322; b) Model Number ART1160, UDI/DI EA 10653160355762, UDI/DI CS 00653160355765; c) Model Number ART1180, UDI/DI EA 10653160355472, UDI/DI CS 00653160355475; d) Model Number ART775B, UDI/DI EA 10653160353560, UDI/DI CS 00653160353563; e) Model Number ART890A, UDI/DI EA 10653160356677, UDI/DI CS 00653160356670; f) Model Number ART995, UDI/DI EA 10193489190502, UDI/DI CS 20193489190509; g) Model Number P42453, UDI/DI EA 10653160323792, UDI/DI CS 00653160323795 |
|---|
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-2193-2023%22
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