Z-1821-2015Class II

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with...

Name: Z-1821-2015 Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with...
Creator: Unomedical As
Published: 2015-05-21
License: https://open.fda.gov/license/

Unomedical A/S / initiated 2015-05-21 / Terminated / root cause: manufacturing process

FDA source

Unomedical As began a recall of Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of... on 2015-05-21. FDA classified it as Class II and gives the reason as "Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1821-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-21
Posted: 2015-06-19
Terminated: 2017-01-23
Recalling firm: Unomedical A/S
Product: Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
Root cause tag: manufacturing process
FDA 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 identified in the letter.
Quantity in commerce: 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, Sweden, Switzerland, Netherlands, Turkey, United Arab Emirates, and United Kingdom.
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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1821-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1821-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-19

Product code FPA

K120395Class IINeria Multi Subcutaneous Infusion SetUnomedical Devices S.A DE C.V. / cleared 2012-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)