Recall Z-0229-2016— Resource Optimization & Innovation Llc
Class II · Terminated
Class II FDA medical device recall by Resource Optimization & Innovation Llc, initiated 2015-08-25, terminated 2017-04-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.. Reason: The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set..
- Recalling firm
- Resource Optimization & Innovation Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-25
- Terminated
- 2017-04-06
- Firm location
- Springfield, MO, United States
Product description
Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.
Reason for recall
The kits contain pressure monitoring kits or sets which are being recalled as a result of flow restriction issues in the trifurcated IV set.
Data sourced from openFDA. This site is unofficial and independent of the FDA.