Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Reported: November 27, 2019 Initiated: April 19, 2019 #Z-0025-2020
Product Description
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Reason for Recall
Reports of aspirating biopsy needle breakage
Details
- Recalling Firm
- AURIS HEALTH INC
- Units Affected
- 158
- Distribution
- US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.
- Location
- Redwood City, CA
Frequently Asked Questions
What product was recalled? ▼
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120. Recalled by AURIS HEALTH INC. Units affected: 158.
Why was this product recalled? ▼
Reports of aspirating biopsy needle breakage
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2019. Severity: Moderate. Recall number: Z-0025-2020.
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