Recall Z-1524-2013— Bard Peripheral Vascular Inc

Name: FDA recall Z-1524-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-16

Class II · Terminated

Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2013-04-16, terminated 2014-01-30. It names one FDA 510(k) clearance: K993785. Product: BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.. Reason: Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use..

Recalling firm: Bard Peripheral Vascular Inc
Classification: Class II
Status: Terminated
Initiated: 2013-04-16
Terminated: 2014-01-30
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K993785 — ULTRACLIP TISSUE MARKERInrad·cleared 2000-02-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.

Reason for recall

Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.