Galt Medical Corporation: Medical Device Recall in 2018 - (Recall #: Z-2558-2018)

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:

1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a) KCL-102-05; b) KCL-102-07 4) VSI Micro-HV Introducer Kit, Sterile EO, Catalog #: a) CLI-800-33; b) CLI-810-16;

Product Classification:

Class II

Date Initiated: May 2, 2018

Date Posted: August 8, 2018

Recall Number: Z-2558-2018

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: 3160

Code Information:

Lot #: 1) a) S18015025; b) S18015026, c) S18015027; d) S18046198; 2) a) G17356364; 3) a) S18016057, S18106396, b) S18080265 4) a) S18032092, S18032093, S18032094; b) S18046163;

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