Alcon Research, LTD. Recall 92698
Description: Legion FMS Pak
Alcon Research, LTD. Recall 92698 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2409-2023 |
| Event ID | 92698 |
| Event Description | Legion FMS Pak |
| Product Type | Devices |
| 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, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, French Guayana, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Isle of Man, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Montenegro, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Fed., Saint Martin, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, USA, USVI, Utd. Arab Emir., Uzbekistan, Vietnam, and Yemen. |
| Quantity | 2,628 units |
| Recall Reason | Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench. |
| Device Classification | 20230823 |
| Device Code Info | Catalog No. 8065753164, 8065753165, 8065753166; Product Code 100205822, 100207728, 100207729; UDI-DI: 380657531646, 380657531653, 380657531660; Lots 14YTR7, 153UW1, 156YMH, 157R2M. |
| Center Classification Date | 20230816 |
| Recall Initiation Date | 20230628 |
| Recalling Firm | Alcon Research, LTD. |
| Initial Notification | Letter |
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