FDAFDA · Food and drugs·Recall number Z-2218-2018
CAN 5F SINGLE XCELA PICC, Catalog Number 60M701531
Published June 20, 2018 · Recall initiated: May 10, 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
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Distributor
- The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
- Lot
- UPN: H96560M7015311; Lot: 5299826, 5312185
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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