FDAFDA · Food and drugs·Recall number Z-2563-2018
Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
Published August 8, 2018 · Recall initiated: May 2, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Galt Medical Corporation
- Distributor
- 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
- Lot #: a) 18043101; b) 18124426, 18120765
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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