TVS LPA, Catalog #: DIL-059-00
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-2564-2018
- Quantity
- 3530
- 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 #: 17338821, 18019045
Root Cause
Other
Action Taken
On approximately 05/01/2018 recall letters and customer response forms were mailed to all consignees.
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