FDA Device recall Z-0990-2014
Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing by Perrigo Diabetes Care, citing 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 c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0990-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-20 |
| Published | 2014-02-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Perrigo Diabetes Care |
| Distribution | US |
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
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
Identifiers
| upc | 7613117009502 |
|---|---|
| code_info | 400064, 400069, 400070, & 400072 UPC: 7613117009502 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0990-2014%22
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