Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Set...
FDA Recall #Z-0990-2014 — Class II — December 20, 2013
Product Description
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
Recalling Firm
Perrigo Diabetes Care — Alpharetta, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
7924 units
Distribution
Nationwide Distribution including GA & TX
Code Information
400064, 400069, 400070, & 400072 UPC: 7613117009502
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated