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Class 2 Device Recall Drainer Centesis Catheter |
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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-2560-2018 |
Recall Event ID |
80021 |
Product Classification |
Cadiovascular, Introducer catheter - Product Code KGZ
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Product |
1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15,
2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,
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Code Information |
Lot #: 1) a) 18037128, 18057123; b) 18026062, 18026063; c) 18050076, 18092077; 2) a) 17303409, 17313728, 17324971, 17324972, 17340309, 17340310, 17355684; b) 17303412, 17311642, 17335910, 17340312, 17340314, 17355685, 17355686, 17355687; c) 17311643, 17314335, 17349257, 18026356, 18033604, 18047978, 18096513, 18110747; d) 17314337, 17321338, 17352567, 18005181 |
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 |
13210 |
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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