Recall Z-1586-2015— Bard Peripheral Vascular Inc
Class II · Terminated
Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2015-04-09, terminated 2015-09-25. It names one FDA 510(k) clearance: K133948. Product: BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color-coded according to the various gauge sizes e.g., yellow=20 gauge, pink=18 gauge, purple=16 gauge, and green=14 gauge.. Reason: The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues..
- Recalling firm
- Bard Peripheral Vascular Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-09
- Terminated
- 2015-09-25
- Firm location
- Tempe, AZ, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color-coded according to the various gauge sizes e.g., yellow=20 gauge, pink=18 gauge, purple=16 gauge, and green=14 gauge.
Reason for recall
The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.
Data sourced from openFDA. This site is unofficial and independent of the FDA.