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;
FDA Recall Z-2193-2023 · Posted 2023-07-20
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Reason for Recall
Firm Action
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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