Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0137-2023 — CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B, CORA1825S/A, CORA2010/A, CORA2010/B, CORA2010S/A, CORA2015/A, CORA2015/B, CORA

U.S. FDA — Device Enforcement · United States · 2022-08-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0137-2023
Date of alert
2022-08-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Merit Medical Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00884450476192
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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