Device recall

Z-2209-2019: EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5…

FDA device recall · Class II · Bard Peripheral Vascular Inc

Key facts

Recall number (Z-number) Z-2209-2019
Recall event 83303
Product EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
Product code KNW
Recalling firm Bard Peripheral Vascular Inc
Recall class Class II
Status Terminated
Termination date Mar 3, 2022
510(k) numbers K040842, K051158
FEI number 2020394

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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