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U.S. Department of Health and Human Services

Class 2 Device Recall Tearaway Introducers

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  Class 2 Device Recall Tearaway Introducers see related information
Date Initiated by Firm May 02, 2018
Create Date July 27, 2018
Recall Status1 Terminated 3 on July 20, 2020
Recall Number Z-2565-2018
Recall Event ID 80021
510(K)Number K000313(Original)  K153533(New  
Product Classification Cadiovascular, Introducer catheter - Product Code DYB
Product Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10;

c) DIL-015-50;

d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07;

n) SPT-003-46
Code Information Lot #: a) 18024880, 18043086, 18066833, 18073282; b) 18039555, 18059249, 18074835;  c) 17363134;  d) 17352818, 18051601; e) 18019228, 18047509; f) 18023833; g)   17356436, 18018694, 18018695, 18040074; h) 18061579; i) 18015027; j) 18019038, 18029067, 18033068, 18075816, 18075817, 18075818; k) 17363816, 18023834, 18026040, 18026072, 18033073, 18033079, 18054248; l) 18005018, 18012032, 18012034, 18012035, 18012036, 18019037, 18026953, 18089355, 18096357, 18096358, 18103359; m) 18047202;  n) 18054349 
Recalling Firm/
Manufacturer		 Galt Medical Corporation
2220 Merritt Dr
Garland TX 75041-6137
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 23777
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
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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