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Terminated

TVS LPA, Catalog #: DIL-059-00

FDA Recall Z-2564-2018 · Posted None

Recalling FirmGalt Medical Corporation
Recall StatusTerminated
Product CodeKGZ
Date Initiated2018-05-02
Date Terminated2020-07-20
Product Quantity3530

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.

Firm Action

On approximately 05/01/2018 recall letters and customer response forms were mailed to all consignees.

Root Cause

Other

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172487Coaxial Dilator Set (Micro-Introducer)Galt Medical Corp. · 2017-10-16K000737COAXIAL DILATOR SETXentek Medical, Inc. · 2000-08-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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