regard Item Number: 800526, Sterile, ET0610 - Head and Neck - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Reported: October 14, 2015 Initiated: April 22, 2015 #Z-0048-2016
Product Description
regard Item Number: 800526, Sterile, ET0610 - Head and Neck - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, 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.
Details
- Recalling Firm
- Resource Optimization & Innovation Llc
- Units Affected
- 156 kits
- Distribution
- Distribution was made to LA, MS, and TX.
- Location
- Springfield, MO
Frequently Asked Questions
What product was recalled? ▼
regard Item Number: 800526, Sterile, ET0610 - Head and Neck - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure. Recalled by Resource Optimization & Innovation Llc. Units affected: 156 kits.
Why was this product recalled? ▼
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 14, 2015. Severity: Moderate. Recall number: Z-0048-2016.
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