Recall Z-2210-2019
Bard Peripheral Vascular Inc · initiated May 2, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical) - REF ECP0110GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
Codes / lots: Lot numbers VTCT0273, VTCT0308, VTCT0309, VTCU0351, VTCU0352, VTCW0451, VTCW0452, VTCW0453, VTCX0485, VTCX0486, VTCX0487, VTCY0548, VTCY0549, VTCY0550, VTCZ0642, VTCZ0643, VTCZ0644, and VTCZ0645.
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: Component change control
Action taken
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.
Details
- Recall number
- Z-2210-2019
- Initiated
- May 2, 2019
- Terminated
- March 3, 2022
- Product code
- KNW – Instrument, Biopsy
- 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…
- Recalling firm
- Bard Peripheral Vascular Inc, Tempe, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2209-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | 05/02/2019Terminated |
| Z-2211-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | 05/02/2019Terminated |
| Z-2212-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | 05/02/2019Terminated |
| Z-2213-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | 05/02/2019Terminated |
| Z-2214-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | 05/02/2019Terminated |