Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Recall Z-1821-2015 · Posted 2015-06-19
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Recalling FirmUnomedical As
Recall StatusTerminated
Product CodeFPA
Date Initiated2015-05-21
Date Terminated2017-01-23
Product Quantity22,976,870 units
Reason for Recall
Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
Firm Action
Each consignee was sent an "Urgent Field Safety Notice Regarding Steel Cannula Infusion Sets" on 5/21/2015 via Express Mail. This notification identified the affected product as well as the reason for the recall. It also contained instructions on how to use the product. Customers were to contact their health care provider if they suspected that a needle had broken off and remained under the skin. Diabetic patients were to monitor their blood sugar and non diabetic patients were to monitor symptoms which would indicate drug delivery had failed. Questions should be directed to the persons identified in the letter.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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