Recall Z-0078-2016— Resource Optimization & Innovation Llc
Class II · Terminated
Class II FDA medical device recall by Resource Optimization & Innovation Llc, initiated 2015-04-22, terminated 2017-03-28. FDA's recall record names no specific 510(k) clearance for this event. Product: regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure. Reason: The kits contain an equipment glove component which may contain splits or holes compromising the sterility..
- Recalling firm
- Resource Optimization & Innovation Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-22
- Terminated
- 2017-03-28
- Firm location
- Springfield, MO, United States
Product description
regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Reason for recall
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.