Medical device recalls Moderate risk

Unomedical As recalls Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps…

Recall date
May 21, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1821-2015
FDA classification
Class II
Brand / firm
Unomedical As
Sold / distributed
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,…

Why it was recalled

Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

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