Recall Z-0990-2014— Perrigo Diabetes Care
Class II · Terminated
Class II FDA medical device recall by Perrigo Diabetes Care, initiated 2013-12-20, terminated 2014-08-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-20
- Terminated
- 2014-08-05
- Firm location
- Alpharetta, GA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.