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Alcon Research, Ltd. recalls Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 2
Recalled July 8, 2015 · FDA recall Z-1940-2015 · Alcon Research
Hazard
Insufficient seal on the outside packaging, potentially affecting the sterility of the product. · FDA Class II
Units
35,475 units
Sold at
Worldwide Distribution-US (nationwide) and the countries of Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Hong Kong, Hungary, India, International APL, Italy, Japan, Kenya, Korea, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Poland, Russia, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
Description
Insufficient seal on the outside packaging, potentially affecting the sterility of the product.
Product
Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use probe for performing vitrectomy surgical procedures while using the Alcon Accurus vitrectomy console.
Manufacturer(s)
Alcon Research, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →