Recall Z-0138-2023— Merit Medical Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2022-08-03. It names one FDA 510(k) clearance: K180450. Product: CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA1815SB/CNB, CORCA1820SB/CNB, CORCA2015SB/CNB, CORCA2020SB/CNB. Reason: Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury..
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-08-03
- Firm location
- South Jordan, UT, 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
CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA1815SB/CNB, CORCA1820SB/CNB, CORCA2015SB/CNB, CORCA2020SB/CNB
Reason for recall
Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.
Data sourced from openFDA. This site is unofficial and independent of the FDA.