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U.S. Department of Health and Human Services

Class 2 Device Recall Elite HV Introducer

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  Class 2 Device Recall Elite HV Introducer 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-2562-2018
Recall Event ID 80021
510(K)Number K043525  K173287  
Product Classification Cadiovascular, Introducer catheter - Product Code DYB
Product Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055
Code Information Lot #: a) 18032057, 18032058; b) 18001013, 18046016, 18162838; c) 18019455 18019456, 18019457, 18019458, 18019460, 18047461, 18047462, 18047463; d) 17363374, 18116090  
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 10950
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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