Infusion Set — Class II medical device recall Z-0355-2017
Terminated recall by Unomedical As, reported 2016-11-09, distributed in CA, IN, PA. Tubing detachment
| Recall number | Z-0355-2017 |
|---|---|
| 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 | 1,295,515 units |
| Reason classes | device malfunction |
Product
Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" 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-0355-2017. 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.