BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Reported: January 1, 2020 Initiated: October 25, 2019 #Z-0724-2020
Product Description
BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Reason for Recall
During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.
Details
- Recalling Firm
- Bard Peripheral Vascular Inc
- Units Affected
- 727,034 units
- Distribution
- Worldwide distribution - US Nationwide distribution and countries of Australia, Canada, Europe, Middle East, Africa, Latin America, Asia Pacific.
- Location
- Tempe, AZ
Frequently Asked Questions
What product was recalled? ▼
BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.. Recalled by Bard Peripheral Vascular Inc. Units affected: 727,034 units.
Why was this product recalled? ▼
During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2020. Severity: Moderate. Recall number: Z-0724-2020.
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