Baxter Healthcare Corporation: 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 CAS

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Global, US: NY, IL Quantity: 3547 units Lot/code info: a) VS100-2, UDI/DI 732094224214; b) VS100-4, UDI/DI 732094224191; c) VS100-7, UDI/DI 732094224092; d) VS100S-2, UDI/DI 732094224177; e) VS100S-4, UDI/DI 732094224153; f) VS100S-7, UDI/DI 732094224085; g) VS100S-Z, UDI/DI 732094294217; h) 106364, UDI/DI 732094246964; i) 106366, UDI/DI 732094319927; j) 106368, UDI/DI 732094248692

UPC codes

732094224214, 732094224191, 732094224092, 732094224177, 732094224153, 732094224085, 732094294217, 732094246964, 732094319927, 732094248692

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.