SureT G29 6mm — Class II medical device recall Z-0360-2017
Terminated recall by Unomedical As, reported 2016-11-09, distributed in CA, IN, PA. Tubing detachment
| Recall number | Z-0360-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unomedical As, Roskilde, Denmark |
| Recall initiated | 2014-11-07 |
| Classified | 2016-11-03 |
| Reported by FDA | 2016-11-09 |
| Terminated | 2016-11-16 |
| Distributed | CA, IN, PA |
| Countries outside the US | CA, JP, KR |
| Quantity | 4,748,000 units |
| Reason classes | device malfunction |
Product
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Reason for recall
Tubing detachment
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0360-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.