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.

Recall number

Z-1821-2015

Recalling firm

Unomedical As

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.

Status

Terminated

Initiated

2015-05-21

Posted

2015-06-19

Terminated

2017-01-23

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 identified in the letter.

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, Sweden, Switzerland, Netherlands, Turkey, United Arab Emirates, and United Kingdom.

Lot, serial or model codes

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510(k) numbers

["K120395"]

PMA numbers

not on file

Product code

FPA

Firm FEI

1000477110

Firm city

Roskilde

Firm state

not on file

Firm country

Denmark

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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