Z-2212-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- May 2, 2019
- Termination Date
- March 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 239 units
Product Description
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (Vertical) - REF ECP0112GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
Reason for Recall
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
Distribution Pattern
Worldwide distribution - US Nationwide distribution, including Puerto Rico. There was government and foreign distribution and no military distribution. Foreign distribution was made to Canada, Algeria, Australia, Austria, Belgium, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, Iceland, India, Ireland, Italy, Japan, Korea, Kuwait, Luxembourg, Malaysia, Martinique, Monaco, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.
Code Information
Lot number VTCW0467.