Alcon Research, LTD.: Legion FMS Pak

Hazard

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

Details from the source

Reason for recall: Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench. Distribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, Albania, Algeria, Andorran, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bermuda, Botswana, Brazil, Brunei Daruss., Bulgaria, Burma, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Quantity: 2,628 units Lot/code info: Catalog No. 8065753164, 8065753165, 8065753166; Product Code 100205822, 100207728, 100207729; UDI-DI: 380657531646, 380657531653, 380657531660; Lots 14YTR7, 153UW1, 156YMH, 157R2M.

UPC codes

380657531646, 380657531653, 380657531660

Source

Official record: FDA (Device enforcement) ↗

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