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.
FDA Recall Z-0990-2014 · Posted 2014-02-19
Recalling FirmPerrigo Diabetes Care
Recall StatusTerminated
Product CodeFKB
Date Initiated2013-12-20
Date Terminated2014-08-05
Product Quantity7924 units
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
Firm Action
Perrigo Diabetes Care sent a recall notice dated December 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to segregate the affected productt and request return of all undistributed/unused sets from their customer warehouses to Omni Manufacturing Services S.A. de C.V., Parque Industrial Queretaro, La Noria Lt. 13. Mz 3 No. 125, Santo Rosa Jauregui, MX-76220 Santiago de Queretaro. Customers were instructed to distribute the attached "Urgent Field Safety Notice" to all users or patients who have been shipped any products from the affected lots.
Customers with questions were instructed to call Perrigo Diabetes Care at 1-888-775-1997.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution including GA & TX
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.