Galt Medical Corporation recalls Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,

Recall date

May 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2563-2018

FDA classification

Class II

Brand / firm

Galt Medical Corporation

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,