Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
Recall
- Recall Number
- Z-1821-2015
- Event Number
- 71332
- FEI Number
- 1000477110
- Product Code
- FPA
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- May 21, 2015
- Posted
- June 19, 2015
- Terminated
- January 23, 2017
- Address
- Unomedical As Aholmvej 1 3 Osted Roskilde Denmark
Description
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 has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
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.
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.
22,976,870 units