Skip to content
Recall Observatory FDA recall evidence

Device product

TVS LPA, Catalog #: DIL-059-00

Z-2564-2018

May 02, 2018

Class II

Product summary

Firm
Galt Medical Corporation
Event
Event 80021
Status
Terminated
Classification
Class II
Quantity
3530
Official record key
device-enforcement:Z-2564-2018

Official wording

Reason: 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.

Code information: Lot #: 17338821, 18019045

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.