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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Code-Lot (OUS Distribution Only): CORA1410/B- I2206909, I2318475, I2291980, I2286704; CORA1410S/B- I2206888; CORA1415/B- I2213361; CORA1615S/B- I2114518, H1517631, H1715532, H1756745, H1767115, H1771762, H1776067, H1784861, H1800979, H1808121, H1825693, I1781878, I1818817, I1837234, I1843704, I1855418, I1866359, I1952354, I1958525, I1971876, I1990075, I1998862, I2043630, I2070249, I2075810; CORA2010S/B- I2010414; CORCA1410S/B- I2259093; CORCA1410S/CNB- I2305358; CORCA1415S/B- I2210950; CORCA1610/CNB- I2291983; CORCA1615S/CNB- I2330683; CORCA1810SB/CNB- I2305359; CORCA1815SB/CNB- I2170254, I2205164; CORCA1820SB/CNB- I2325912; CORCA2015SB/CNB- I2318903, I2325926; CORCA2020SB/CNB- I2320880
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Merit Medical Systems, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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
Product Codes/Lot Numbers:
Catalog Code-Lot (OUS Distribution Only): CORA1410/B- I2206909, I2318475, I2291980, I2286704; CORA1410S/B- I2206888; CORA1415/B- I2213361; CORA1615S/B- I2114518, H1517631, H1715532, H1756745, H1767115, H1771762, H1776067, H1784861, H1800979, H1808121, H1825693, I1781878, I1818817, I1837234, I1843704, I1855418, I1866359, I1952354, I1958525, I1971876, I1990075, I1998862, I2043630, I2070249, I2075810; CORA2010S/B- I2010414; CORCA1410S/B- I2259093; CORCA1410S/CNB- I2305358; CORCA1415S/B- I2210950; CORCA1610/CNB- I2291983; CORCA1615S/CNB- I2330683; CORCA1810SB/CNB- I2305359; CORCA1815SB/CNB- I2170254, I2205164; CORCA1820SB/CNB- I2325912; CORCA2015SB/CNB- I2318903, I2325926; CORCA2020SB/CNB- I2320880
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0138-2023
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