FDA Device recall Z-2212-2019
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (V…
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (V… by Bard Peripheral Vascular, citing there has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2212-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-02 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
Product
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
There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
Identifiers
| code_info | Lot number VTCW0467. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2212-2019%22
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