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U.S. Department of Health and Human Services

Class 2 Device Recall 2000 vascular with 30 degree option

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 Class 2 Device Recall 2000 vascular with 30 degree optionsee related information
Date Initiated by FirmSeptember 02, 2016
Create DateNovember 08, 2019
Recall Status1 Terminated 3 on December 14, 2020
Recall NumberZ-0353-2020
Recall Event ID 83219
Product Classification Table, examination, medical, powered - Product Code LGX
Product2000 Vascular with 30 Degree option
Code Information 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. 
FEI Number 3003881889
Recalling Firm/
Manufacturer		 Heritage Medical Products, Inc.
10380 County Road 6310
West Plains MO 65775-6331
For Additional Information ContactJason Stasney
417-256-8748
Manufacturer Reason
for Recall		Potential for bed to drop suddenly at the head while a patient is laying on it.
FDA Determined
Cause 2		Device Design
ActionHeritage 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.
Quantity in Commerce167 beds (159 US, 8 OUS)
DistributionNationwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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