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ROi CPS LLC recalls Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, C
Recalled July 27, 2022 · FDA recall Z-1407-2022 · ROi CPS
Hazard
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits. · FDA Class II
Units
86 kits
Sold at
Distribution was made to MO. There was no foreign/military/government distribution.
Description
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
Product
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Manufacturer(s)
ROi CPS LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →