Recall Z-1821-2015 ยท FPA Set, Administration, Intravascular
Unomedical As
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
| Date | Jun 19, 2015 (initiated May 21, 2015) |
| Status | Terminated |
| Reason | Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin. |
| Root cause | Nonconforming Material/Component |
| 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 i |
| Quantity | 22,976,870 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120395 | NERIA MULTI SUBCUTANEOUS INFUSION SET Unomedical Devices S.A DE C.V., May 30, 2012 |