Orbit soft Infusion sets — Class II medical device recall Z-0990-2014
Terminated recall by Perrigo Diabetes Care, reported 2014-02-26, distributed nationwide. Perrigo was notified by our supplier, Ypsomed AG, that they are recalling these batches due to being manufactu
| Recall number | Z-0990-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perrigo Diabetes Care, Alpharetta, GA, United States |
| Recall initiated | 2013-12-20 |
| Classified | 2014-02-19 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2014-08-05 |
| Distributed | Nationwide (US) |
| Quantity | 7,924 units |
| UPC / GTIN / UDI-DI | 07613117009502 |
Product
Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump.
Reason for recall
Perrigo was notified by our supplier, Ypsomed AG, that they are recalling these batches due to being manufactured with a non-conforming female luer-lock connector. The luer-lock connectors are incompatible with standard male luer-lock connectors for use in connection to compatible infusion pumps. Perrigo became was notified of a quality complaint related to this issue on November 20, 2013 from a
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-0990-2014. 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.