Galt Medical Corporation: Medical Device Recall in 2018 - (Recall #: Z-2562-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055

Product Classification:

Class II

Date Initiated: May 2, 2018

Date Posted: August 8, 2018

Recall Number: Z-2562-2018

Event ID: 80021

Reason for Recall:

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.

Status: Terminated

Product Quantity: 10950

Code Information:

Lot #: a) 18032057, 18032058; b) 18001013, 18046016, 18162838; c) 18019455 18019456, 18019457, 18019458, 18019460, 18047461, 18047462, 18047463; d) 17363374, 18116090

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated