Recall Z-2193-2023— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2023-05-18. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-18
- Firm location
- Northfield, IL, United States
Product description
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 for recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Data sourced from openFDA. This site is unofficial and independent of the FDA.