FDAFDA · Food and drugs·Recall number Z-0135-2017
CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
Published October 26, 2016 · Recall initiated: June 27, 2016
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 packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ConMed Corporation
- Distributor
- Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.
- Lot
- Beginning Lot Code 110609X to Ending Lot Code 20160308X
- 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.