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Class 2 Device Recall ELITE HV, Hemostasis Valve Introducer System |
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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
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Product Classification |
Cadiovascular, Introducer catheter - Product Code DYB
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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
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For Additional Information Contact |
David Derrick 214-778-1306
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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.
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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
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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 = DYB and Original Applicant = GALT MEDICAL CORP.
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