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FDA device recall Z-1821-2015 · posted 2015-06-19 · Terminated
Recall details
- Recalling firm
- Unomedical As
- Reason for recall
- Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
- Action taken
- 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
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 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 Kon
- Date initiated
- 2015-05-21
- Date posted
- 2015-06-19
- Date terminated
- 2017-01-23
- Location
- Roskilde, Denmark
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NERIA MULTI SUBCUTANEOUS INFUSION SET (K120395) | Unomedical Devices S.A DE C.V. | 2012-05-30 |