Perrigo Diabetes Care: 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 subcutan

Is my product affected?

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.

• UPC 7613117009502

Check against the official notice below — it lists the full affected range.

What happened

Perrigo Diabetes Care is recalling Orbit soft infusion sets with 9 mm soft cannula and P10 (42") tubing due to a manufacturing defect in the female luer-lock connector. The connectors are non-conforming and incompatible with standard male luer-lock connectors used to attach these sets to compatible infusion pumps. The recall affects 7,924 units distributed nationwide, including Georgia and Texas, across lot codes 400064, 400069, 400070, and 400072 (UPC 7613117009502). Perrigo was notified of a quality complaint related to this issue on November 20, 2013.

The recall source does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

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

Details from the source

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 Distribution: Nationwide Distribution including GA & TX Quantity: 7924 units Lot/code info: 400064, 400069, 400070, & 400072 UPC: 7613117009502

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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