FDA-Device2015-07-01Class II
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
Unomedical As
Hazard
Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
Sold states
Worldwide Distribution -- US, including the states of CA, IL, MN, and PA; and, the countries of Australia, Bahrain, Belgium, Canada, China, Cypress, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Kuwait, Lebanon, Malaysia, Maldives, Oman, Schweiz, South Africa, Spain, Sweden, Switzerland, Netherlands, Turkey, United Arab Emirates, and United Kingdom.
Affected count
22,976,870 units
Manufactured in
Aholmvej 1 3 Osted, Roskilde, Denmark
Products
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1821-2015Don't want to check this manually?
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