Recall Z-1510-2024— Baxter Healthcare Corporation

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-03-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE,PLUG2/EUR, VS100-2; b) SPOT VISION SCREENER,W/O CASE,PLUG4/UK, VS100-4; c) SPOT VISION SCREENER,W/O CASE,PLUG7/SA, VS100-7; d) SPOT VISION SCREENER,W/CASE,PLUG2/EUR, VS100S-2; e) SPOT VISION SCREENER,W/CASE,PLUG4/UK, VS100S-4; f) SPOT VISION SCREENER,W/CASE,PLUG7/SA, VS100S-7; g) SPOT VISION SCREENER W/CASE, BRAZIL, VS100S-Z; h) SPOT VS POWER SUPPLY SET/PLUG2/EUR, 106364; i) SPOT VS POWER SUPPLY SET/PLUG4/UK, 106366; j) SPOT VS POWER SUPPLY SET/PLUG7/SA, 106368; for use during vision screening. Reason: Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards..

Recalling firm

Baxter Healthcare Corporation

Classification

Class II

Status

Ongoing

Initiated

2024-03-26

Firm location

Deerfield, IL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.