| Class 2 Device Recall EnCor Breast Biopsy Probe | |
Date Initiated by Firm | May 02, 2019 |
Create Date | August 07, 2019 |
Recall Status1 |
Terminated 3 on March 03, 2022 |
Recall Number | Z-2214-2019 |
Recall Event ID |
83303 |
510(K)Number | K040842 K051158 |
Product Classification |
Instrument, biopsy - Product Code KNW
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Product | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities. |
Code Information |
Lot numbers VTCV0414, VTCW0469, VTCW0470, VTCY0566, VTCZ0640, VTCZ0648, and VTCZ0649. |
Recalling Firm/ Manufacturer |
Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 Tempe AZ 85281-2438
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For Additional Information Contact | Ms. Janice Norwood 800-321-4254 |
Manufacturer Reason for Recall | There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. |
FDA Determined Cause 2 | Component change control |
Action | The recalling firm issued letters dated 4/19/2019 via FedEx on 4/19/2019 with proof of delivery to the U.S. customers. The letters sent to foreign countries vary depending on the format required for the country. |
Quantity in Commerce | 12,833 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KNW
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