Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055
This recall has been terminated (originally issued May 2, 2018).
- Company
- Galt Medical Corporation
- Recall Initiated
- May 2, 2018
- Terminated
- July 20, 2020
- Recall Number
- Z-2562-2018
- Quantity
- 10950
- Firm Location
- Garland, TX
- Official Source
- View on FDA website ↗
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.
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
Lot / Code Info
Lot #: a) 18032057, 18032058; b) 18001013, 18046016, 18162838; c) 18019455 18019456, 18019457, 18019458, 18019460, 18047461, 18047462, 18047463; d) 17363374, 18116090
Root Cause
Other
Action Taken
On approximately 05/01/2018 recall letters and customer response forms were mailed to all consignees.