Recall Z-0353-2020
Heritage Medical Products, Inc. · initiated September 2, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
2000 Vascular with 30 Degree option
Codes / lots: Serial Numbers: 2030, 1713, 1041, 1191, 1368, 1306, 2052, 1895, 1554, 1618, 1511, 1990, 1659, 2279, 1354, 1547, 1442, 2156, 1536, 1471, 1472, 1473, 1548, 1549, 1550, 1551, 1750, 1242, 1601, 2008, 1946, 1947, 1868, 1865, 1811, 1831, 1832, 2202, 1495, 2082, 2083, 1044, 1571, 1621, 2017, 2203, 2121, 2145, 2054, 1016, 1017, 2284, 1876, 2278, 1039, 1685, 1686,1043, 1307, 1357,2224, 2225, 1852, 1297, 2122, 2123, 1439, 1629, 2059, 1648, 1470, 1046, 1941, 1942, 1943, 1944, 1962, 1421, 885, 887, 1234, 1387, 1388, 1389, 1390, 1391, 1392, 1414, 1447, 1796, 1991, 1992, 1993, 1994, 1995, 1996, 1997, 2004, 1838, 1597, 1707, 1266, 1449, 1513, 1514,1515, 1516, 1661, 1998, 1380, 2094, 1221, 881, 886, 1058, 1095, 1189, 1243, 1267, 1377, 1379, 1399, 1400, 1420, 1453, 1458, 1477, 1498, 1527, 1581, 1608, 1616, 1617, 1654, 1676, 1677, 1785, 1814, 1872, 1904, 1905, 1906, 1907, 1917, 1918, 1961, 1973, 1974, 1975, 1984, 1985, 1999, 2000, 2001, 2002, 2012, 2013, 2014, 2029, 2046, 2055, 2056, 2057, 2063, 1708, 1793, 1794.
Reason for recall
Potential for bed to drop suddenly at the head while a patient is laying on it.
FDA-determined cause: Device Design
Action taken
Heritage Medical Products, Inc. notified customers on about 09/02/2016 via "Advisory Notice." Customers were informed that Heritage Medical has designed a reinforcement kit as a correction, which will be supplied to customers. Customers were instructed to contact Heritage Medical, provide the serial number of their bed to ensure it is affected, and Heritage Medical will provide a free kit that will reinforce the area on the affected devices that has experienced failures. The contact information is a follows: Heritage Medical Products, Inc., ATTN.: Trunnion Reinforcement Kit, 10380 CR 6310, West Plains, MO 65775, (888) 256-8748.
Details
- Recall number
- Z-0353-2020
- Initiated
- September 2, 2016
- Terminated
- December 14, 2020
- Product code
- LGX – Table, Examination, Medical, Powered
- Quantity
- 167 beds (159 US, 8 OUS)
- Distribution
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, OH, OK, OR, PA, SC, TX, UT, VA, WI, WY, PR. International distribution to Canada, Saudi Arabia, Trinidad & Tobago.
- Recalling firm
- Heritage Medical Products, Inc., West Plains, MO