Merit Medical Systems, Inc. Recall 90804
Description: 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, CORA2015S/A, CORA2020/A, CORA2020/B, CORCA1410/A, CORCA1410/B, CORCA1415/A, CORCA1415/B, CORCA1610/A, CORCA1610/B, CORCA1610S/B, CORCA1615/A, CORCA1615/B, CORCA1615S/B, CORCA1810B/A, CORCA1810B/B, CORCA1810SB/A, CORCA1810SB/B, CORCA1815B/A, CORCA1815B/B, CORCA1815SB/A, CORCA1815SB/B, CORCA1820B/A, CORCA1820B/B, CORCA1820SB/A, CORCA1820SB/B, CORCA1825B/A, CORCA1825SB/B, CORCA2010B/A, CORCA2010B/B, CORCA2010SB/A, CORCA2010SB/B, CORCA2015B/A, CORCA2015B/B, CORCA2015SB/A, CORCA2015SB/B, CORCA2020B/A, CORCA2020B/B
Merit Medical Systems, Inc. Recall 90804 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0137-2023 |
| Event ID | 90804 |
| Event Description | 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, CORA2015S/A, CORA2020/A, CORA2020/B, CORCA1410/A, CORCA1410/B, CORCA1415/A, CORCA1415/B, CORCA1610/A, CORCA1610/B, CORCA1610S/B, CORCA1615/A, CORCA1615/B, CORCA1615S/B, CORCA1810B/A, CORCA1810B/B, CORCA1810SB/A, CORCA1810SB/B, CORCA1815B/A, CORCA1815B/B, CORCA1815SB/A, CORCA1815SB/B, CORCA1820B/A, CORCA1820B/B, CORCA1820SB/A, CORCA1820SB/B, CORCA1825B/A, CORCA1825SB/B, CORCA2010B/A, CORCA2010B/B, CORCA2010SB/A, CORCA2010SB/B, CORCA2015B/A, CORCA2015B/B, CORCA2015SB/A, CORCA2015SB/B, CORCA2020B/A, CORCA2020B/B |
| Product Type | Devices |
| Distribution | Worldwide distribution - US National distribution including in the states of FL, IL, OH, PA, CA, WI, VA, AZ, AR, MS, TN, MO, MA, MI, NY, NE, TX, WA, MN, LA, DE, IN, AL, NJ, OR, MD, GA, CT, OK, UT, KS, NC, CO, KY, WV, AK, NV, RI, SC, ND, NH, MT and the countries of Finland, Denmark, United Arab Emirates, Spain, Sweden, Norway, Jordan, Australia, Germany, Austria, Italy, United Kingdom, France, Canada, Mexico, Puerto Rico, Chile, Reunion, Belgium, Switzerland, Japan, South Africa, Qatar, Russian Federation, Hungary, Thailand, Namibia, Colombia, New Zealand, Netherlands, Saudi Arabia, Costa Rica, Oman, Cyprus, Slovenia, Croatia, China. |
| Quantity | 1822 |
| Recall 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. |
| Device Classification | 20221102 |
| Device Code Info | Catalog Code-Lot/UDI: CORA1610/B-I2075805, I2093969, I2101330, I2124107, I2233501, I2286703, I2325899/00884450476192; CORA1610S/B-I2138037, I2352845/00884450476222; CORA1615/B-H1408433, H1462686, I1863888, I2127448, I2170247, I2259080/00884450476253; CORA1810/A-H1715532, H1756745, H1767115, H1771762, H1776067, H1784861, H1800979, H1808121, H1825693/00884450316405; CORA1810/B-I1781878, I1818817, I1837234, I1843704, I1855418, I1866359, I1952354, I1958525, I1971876, I1990075, I1998862, I2043630, I2070249, I2075810, I2093993, I2114550, I2116110, I2124108, I2127451, I2137798, I2155289, I2206046, I2243065, I2263876, I2263877, I2282032, I2291981, I2297372, I2385808/00884450476116; CORA1810S/B-I1877912, I1877916, I1902603, I1971867, I1998851, I2033178, I2070341, I2075809, I2124109, I2127455, I2170248, I2370120/00884450477625; CORA1815/A-H1733631, H1734003, H1739133, H1756746, H1771770, H1795481, H1800980, H1807701/00884450316412; CORA1815/B-I1821113, I1838444, I1855417, I1920169, I1920191, I1946564, I1952362, I1989173, I1990074, I2033176, I2070349, I2075808, I2093995, I2114555, I2116111, I2124110, I2127456, I2137805, I2170249, I2201366, I2233502, I2263885, I2269827, I2325901, I2349440/00884450477618; CORA1815S/A-H1756747, H1784863/00884450316528; CORA1815S/B-I1869477, I1874063, I2075806, I2114557, I2127463, I2325902/00884450477601; CORA1820/A-H1375632, H1382959, H1718587, H1734004, H1739135, H1756748, H1762731, H1771773, H1771881, H1784864, H1815597/00884450316429; CORA1820/B-I1823060, I1971866, I2114564, I2137809, I2170250, I2303053, I2385809/00884450477595; CORA1820S/A-H1739136, H1790841/00884450316535; CORA1825/A-H1749790, H1762724, H1808022, H1815598/00884450316436; CORA1825/B-I1843706, I1958504, I2234738, I2239042/00884450477571; CORA1825S/A-H1790845/00884450316542; CORA2010/A-H1784872, H1815600/00884450316443; CORA2010/B-I1863885, I2201378, I2206047, I2237417/00884450477557; CORA2010S/A-H1692834, H1776070/00884450316559; CORA2015/A-H1795483/00884450316450; CORA2015/B-I1823512, I1860367, I1962715, I2140223, I2243072, I2283710, I2303054, I2330668/00884450477526; CORA2015S/A-H1697709, H1771823, H1784884, H1795484/00884450316566; CORA2020/A-H1815606/00884450316467; CORA2020/B-I1781880, I1971845, I2007291, I2228365/00884450477496; CORCA1410/A-H1639707/00884450316580; CORCA1410/B-I2244480, I2384730/00884450476284; CORCA1415/A-, H1776075/00884450316597; CORCA1415/B-I2191846, I2286700, I2318838, I2325906/00884450476314; CORCA1610/A-H1428538, H1714401/00884450316603; CORCA1610/B-I1971855, I1998714, I2114620, I2170251, I2201382, I2233505, I2318858, I2343154/00884450476338; CORCA1610S/B-I1874064, I2010416/00884450476345; CORCA1615/A-H1703701/00884450316610; CORCA1615/B-I1845903, I1888547, I1920175, I1962716, I1998860, I2103685, I2137221, I2137223, I2170252, I2237426, I2286696, I2297374, I2303056, I2330680, I2385810/00884450476352; CORCA1615S/B-I2114626, I2246748/00884450476369; CORCA1810B/A-H1718595, H1734012, H1749798, H1756750, H1771846, H1776080, H1782158, H1790850, H1800985, H1808042/00884450316627; CORCA1810B/B-I1814729, I1838323, I1843705, I1845904, I1869474, I1877911, I1888548, I1902611, I1920161, I1946561, I1946566, I1958530, I1962714, I1990098, I1990104, I1998856, I2025072, I2070266, I2070374, I2093853, I2101369, I2104884, I2114628, I2114714, I2114715, I2116109, I2124195, I2127511, I2150947, I2150948, I2150949, I2159264, I2165513, I2165514, I2201386, I2221444, I2286695, I2303061, I2330685, I2343157, I2385811/00884450476376; CORCA1810SB/A-H1733634, H1800986/00884450316801; CORCA1810SB/B-I1862927, I1920180, I2033140, I2114634, I2233507, I2303065, I2330686/00884450476383; CORCA1815B/A-H1476238, H1608916, H1714408, H1734014, H1734016, H1743880, H1749800, H1749802, H1762717, H1771848, H1776082, H1782159, H1790847, H1795487, H1807720/00884450316634; CORCA1815B/B-I1827256, I1838326, I1843709, I1845905, I1860329, I1860365, I1877914, I1888549, I1902608, I1902609, I1920165, I1920186, I1946560, I1946567, I1952368, I1958533, I1962702, I1971860, I1971861, I1990097, I1990103, I2007293, I2058398, I2061959, I2062021, I2065393, I2075813, I2075839, I2094063, I2098053, I2102664, I2105077, I2114651, I2114652, I2124197, I2127514, I2127515, I2150950, I2150952, I2159275, I2159276, I2170253, I2201393, I2217616, I2281931, I2318869, I2330533, I2330692, I2336279, I2343163, I2349439, I2357134, I2385813, I2385814/00884450476390; CORCA1815SB/A-H1714409, H1743881, H1756752, H1762715/00884450316740; CORCA1815SB/B-I1838328, I1845906, I1877918, I1958536, I2061956, I2075811, I2093850, I2094072, I2233509, I2325909, I2330694, I2399997/00884450476406; CORCA1820B/A-H1718598, H1733635, H1734019, H1749803, H1756754, H1762714, H1771883, H1776084, H1790851, H1807721/00884450316641; CORCA1820B/B-I1827257, I1845907, I1902605, I1902607, I1920166, I1946562, I1971929, I1990094, I1998850, I1998858, I2007294, I2094075, I2103689, I2114708, I2124200, I2127516, I2150980, I2159282, I2159283, I2233510, I2286679, I2343166, I2352856/00884450476413; CORCA1820SB/A-H1733637/00884450316757; CORCA1820SB/B-I2137856, I2325911/00884450476437; CORCA1825B/A-H1718603/00884450316658; CORCA1825B/B-I1946563, I2137863, I2201410, I2265757, I2325913/00884450476451; CORCA1825SB/B-I2156607/00884450476468; CORCA2010B/A-H1445217, H1703705, H1708690, H1718606, H1718607, H1749806, H1762738, H1771884, H1807725, H1815614/00884450316665; CORCA2010B/B-I18210937/I1845908, I1862929, I1874055, I1877913, I1958538, I1971927, I1990070, I2075817, I2094080, I2114709, I2127519, I2170256, I2217622, I2325922/00884450476475; CORCA2010SB/A-H1749807/00884450316771; CORCA2010SB/B-I1874058, I1902604, I1998852, I2122957, I2233511/00884450477632; CORCA2015B/A-H1624841, H1639711, H1657959, H1697713, H1708691, H1714416, H1718609, H1733639, H1734020, H1743882, H1749810, H1771851, H1776086, H1784915, H1790853, H1807727/00884450316672; CORCA2015B/B-I1827258, I1855420, I1862900, I1873128, I1874060, I1888545, I1902614, I1920156, I1952374, I1990072, I1998863, I2070355, I2080473, I2094083, I2114711, I2116112, I2124201, I2127521, I2137868, I2159284, I2191857, I2246760, I2263980, I2287299, I2303068, I2352880, I2370145/00884450477649; CORCA2015SB/A-H1662694, H1733642, H1739148, H1771853, H1776087, H1807729, H1815615/00884450316788; CORCA2015SB/B-I1827270, I1845912, I1862899, I2080472, I2170257, I2201414/00884450477656; CORCA2020B/A-H1662697, H1692861, H1708693, H1718613, H1756755, H1771854, H1776088, H1790855, H1807731/00884450316689; CORCA2020B/B, I1827272, I1845913, I1869475, I1874065, I1877915, I1971882, I1990071, I2070361, I2075814, I2114712, I2151307, I2170259, I2201416, I2330716/00884450477663; CORCA2020SB/B-I2263985, I2297377/00884450477670; 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| Center Classification Date | 20221027 |
| Recall Initiation Date | 20220803 |
| Recalling Firm | Merit Medical Systems, Inc. |
| Initial Notification | Letter |
| Similar To |