Device 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.
Z-0990-2014
Product summary
- Event
- Event 67154
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7924 units
- Official record key
device-enforcement:Z-0990-2014
Official wording
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
Code information: 400064, 400069, 400070, & 400072 UPC: 7613117009502
Distribution pattern: Nationwide Distribution including GA & TX
Derived failure modes
-
Unknown
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