FDAFDA · Food and drugs·Recall number Z-0902-2013
Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
Published March 13, 2013 · Recall initiated: January 31, 2013
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
Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Salyer Prn Biomedical
- Distributor
- Distributed in the states of MA,CA, and WI.
- Lot
- Serial Numbers: CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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