FDA-Device2018-08-08Class II
Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
Galt Medical Corporation
Hazard
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
Sold states
U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea
Affected count
300
Manufactured in
2220 Merritt Dr, N/A, Garland, TX, United States
Products
Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2563-2018Don't want to check this manually?
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