Galt Medical Corporation: Medical Device Recall in 2018 - (Recall #: Z-2561-2018)

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) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03

Product Classification:

Class II

Date Initiated: May 2, 2018

Date Posted: August 8, 2018

Recall Number: Z-2561-2018

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: 8350

Code Information:

Lot #: 1) a) G18046082, G18046083, G18046084, G18046085; b) G18031106, G18031199, G18046076; c) G18030048, G18030049; d) G18030050, G18030204; 2) a) G18003035, G18101170; b) G18003036, G18003037, G18003038

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