FDA-Device2014-02-26Class II
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.
Perrigo Diabetes Care
Hazard
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
Sold states
Nationwide Distribution including GA & TX
Affected count
7924 units
Manufactured in
3780 Mansell Rd Ste T50, Alpharetta, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0990-2014Don't want to check this manually?
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