Legion FMS Pak
Reported: August 23, 2023 Initiated: June 28, 2023 #Z-2409-2023
Product Description
Legion FMS Pak
Reason for Recall
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Details
- Recalling Firm
- Alcon Research, LTD.
- Units Affected
- 2,628 units
- 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.
- Location
- Sinking Spring, PA
Frequently Asked Questions
What product was recalled? ▼
Legion FMS Pak. Recalled by Alcon Research, LTD.. Units affected: 2,628 units.
Why was this product recalled? ▼
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 23, 2023. Severity: Moderate. Recall number: Z-2409-2023.
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