FDAFDA · Food and drugs·Recall number Z-0802-2014
Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
Published January 29, 2014 · Recall initiated: October 25, 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
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Civco Medical Instruments Inc
- Distributor
- Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.
- Lot
- Lot #'s: M441670, M469970, M469980, M469990, M484910, M484920, M516200, M516210, M516220, M533340, M533350, M533360, M533370, M533380, M533970, M533980, M533990, M534000, M544650, M544660, M544670, M550150, M551490, M554940, M554950, M556540, M556550, M559560, M560740, M575850, M578310, M581730, M591090, M591100, M591110, M591120, M591130, and M599570
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.