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U.S. Department of Health and Human Services

Class 2 Device Recall ELITE HV, Hemostasis Valve Introducer System

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  Class 2 Device Recall ELITE HV, Hemostasis Valve Introducer System 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-2558-2018
Recall Event ID 80021
510(K)Number K043525  K173287  
Product Classification Cadiovascular, Introducer catheter - Product Code DYB
Product 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36;

2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14;

3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a) KCL-102-05; b) KCL-102-07

4) VSI Micro-HV Introducer Kit, Sterile EO, Catalog #: a) CLI-800-33; b) CLI-810-16;
Code Information Lot #: 1) a) S18015025; b) S18015026, c) S18015027; d) S18046198;  2) a) G17356364;   3) a) S18016057, S18106396, b) S18080265  4) a) S18032092, S18032093, S18032094; b) S18046163;
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 3160
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.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = GALT MEDICAL CORP.
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