Recall Z-2562-2018 ยท DYB Introducer, Catheter
Galt Medical Corporation
Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055
| Date | May 2, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | On approximately 05/01/2018 recall letters and customer response forms were mailed to all consignees. |
| Quantity | 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 |
| FDA record | Open on fda.gov |