medical Class II Updated 2018-08-08

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

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC
Lot/Code Info: Lot #: a) 18043101; b) 18124426, 18120765
View official government recall

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