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U.S. Department of Health and Human Services

Class 2 Device Recall Vascular Dilator

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  Class 2 Device Recall Vascular Dilator 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-2559-2018
Recall Event ID 80021
510(K)Number K000313(Original)  K153533(New  
Product Classification Cadiovascular, Introducer catheter - Product Code DYB
Product 1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12;

2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11;

3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14;

4) Micro-Access Tearaway Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-010-14;

5) Mini Tear Away Introducer Kit, Sterile EO, Rx Only, Catalog #: KIT-027-04;

6) LI-11 Plus G, Sterile EO, Catalog #: KIT-042-11;

7) LI-12 Plus G, Sterile EO, Catalog #: KIT-042-12;

8) Micro-Access Tearaway Introducer Kit, Sterile EO, Catalog #: a) KIT-900-13; b) KIT-900-14; c) KIT-900-17; d) KIT-900-29; e) KIT-901-02; f) KIT-901-02;

9) "Micro-Access" Kit, Sterile EO, Catolog #: KIT-900-88

10) Mini Stick II Microintroducer Kit. Sterile EO, Rx Only, Catalog #: a) KIT-045-05; b) KIT-045-15;
Code Information lot #: 1) 18102478;  2) 18033450;  3) a) 18089973; b) 18031311; c) 18046318; d) 18082001; e) 18040777, 18061334;  4) S17342075;  5) P18015009;  6) S18051159, S18072306;  7) S18072307;  8) a) S18033049, S18064105, S18093202, S18096316; b) S18025037, S18032055, S18032100, S18032101, S18093199, S18096314; c) S18093200; d) S18032056, S18032102, S18052063, S18074161, S18093203, S18096318; e) S18064104, S18093201; f) S18096315;  9) S18018008;  10) a) G18012001, G18064125; b) S18017001
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 9050
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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