EnCor Breast Biopsy Probes recall
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical)…
Why was EnCor Breast Biopsy Probes recalled?
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers VTCT0273, VTCT0308, VTCT0309, VTCU0351, VTCU0352, VTCW0451, VTCW0452, VTCW0453, VTCX0485, VTCX0486, VTCX0487, VTCY0548, VTCY0549, VTCY0550, VTCZ0642, VTCZ0643, VTCZ0644, and VTCZ0645.
- Product
- EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical)…
- Recalling firm
- Bard Peripheral Vascular Inc
- Quantity
- 29,918 units
- Distribution
- 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.
- Recall date
- August 14, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)