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Resource Optimization & Innovation Llc recalls regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The
Recalled October 14, 2015 · FDA recall Z-0032-2016 · Resource Optimization & Innovation
Hazard
The kits contain an equipment glove component which may contain splits or holes compromising the sterility. · FDA Class II
Units
3,099 kits
Sold at
Distribution was made to LA, MS, and TX.
Description
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Product
regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - 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
Manufacturer(s)
Resource Optimization & Innovation Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →