FDAFDA · Food and drugs·Recall number Z-0990-2014
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.
Published February 26, 2014 · Recall initiated: December 20, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Perrigo Diabetes Care
- Distributor
- Nationwide Distribution including GA & TX
- Lot
- 400064, 400069, 400070, & 400072 UPC: 7613117009502
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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