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
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- August 3, 2022
- Posted
- October 27, 2022
- Recall Number
- Z-0137-2023
- Quantity
- 1822
- Firm Location
- Jordan, UT
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.
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.
Lot / 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;
Root Cause
Process change control
Action Taken
On 8/3/2022, recall notices were mailed to customers who were asked to do the following: 1) Identify affected devices, quarantine, discontinue use and distribution, and return to the recalling firm. 2) If product was further distributed, share the recall notice with these customers/users. 3) Complete and return the customer response form. Customers with questions can contact Customer Service at 801-208-4381, 6AM-6PM, Mon-Fri.