| Class 2 Device Recall TVS LPA | |
Date Initiated by Firm | May 02, 2018 |
Create Date | July 27, 2018 |
Recall Status1 |
Terminated 3 on July 20, 2020 |
Recall Number | Z-2564-2018 |
Recall Event ID |
80021 |
510(K)Number | K000737 K172487 |
Product Classification |
Cadiovascular, Introducer catheter - Product Code KGZ
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Product | TVS LPA, Catalog #: DIL-059-00 |
Code Information |
Lot #: 17338821, 18019045 |
Recalling Firm/ Manufacturer |
Galt Medical Corporation 2220 Merritt Dr Garland TX 75041-6137
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For Additional Information Contact | David Derrick 214-778-1306 |
Manufacturer 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. |
FDA Determined Cause 2 | Other |
Action | On approximately 05/01/2018 recall letters and customer response forms were mailed to all consignees. |
Quantity in Commerce | 3530 |
Distribution | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KGZ 510(K)s with Product Code = KGZ
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