Z-2563-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 8, 2018
- Initiation Date
- May 2, 2018
- Termination Date
- July 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300
Product Description
Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
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 Pattern
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
Code Information
Lot #: a) 18043101; b) 18124426, 18120765