Z-2561-2018 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
- 8350
Product Description
1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03
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 #: 1) a) G18046082, G18046083, G18046084, G18046085; b) G18031106, G18031199, G18046076; c) G18030048, G18030049; d) G18030050, G18030204; 2) a) G18003035, G18101170; b) G18003036, G18003037, G18003038