FDAFDA · Food and drugs·Recall number Z-0129-2017
CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 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
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