Recall Z-1668-2013— Medtronic MiniMed
Class I · Terminated
Class I FDA medical device recall by Medtronic MiniMed, initiated 2013-06-07, terminated 2015-06-10. It names one FDA 510(k) clearance: K011071. Product: Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.. Reason: Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin..
- Recalling firm
- Medtronic MiniMed
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-06-07
- Terminated
- 2015-06-10
- Firm location
- Northridge, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
Reason for recall
Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin.
Data sourced from openFDA. This site is unofficial and independent of the FDA.