Recall Z-1260-2023— Bard Peripheral Vascular Inc
Class II · Ongoing
Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2023-02-28. It names one FDA 510(k) clearance: K171953. Product: Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK. Reason: The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility..
- Recalling firm
- Bard Peripheral Vascular Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-28
- 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 Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
Reason for recall
The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.