Events

Retiro De Equipo (Recall) de Bard Access

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Bard Access Systems.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    70430
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1271-2015
  • Fecha de inicio del evento
    2014-08-08
  • Fecha de publicación del evento
    2015-03-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133596
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • Causa
    Some unit packages of bd posiflush sf saline flush syringe 10 ml may exhibit open seals, which could impact product sterility. bard includes these pouched syringes, attached to some configurations of picc kits, port access kits (pak), powerglide kits, midline kits, and convenience kits.
  • Acción
    The firm, BD Medical, sent an "URGENT VOLUNTARY PRODUCT RECALL" letter dated July 22, 2014 and a follow-up "URGENT: Voluntary Product Recall-BD PosiFlush SF Saline Flush Syringe 10mL with rework instructions for applicable Bard Kits" letter dated August 8, 2014 to its customers and distributors. The letters described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory and quarantine product subject to the recall; complete and return the Recall Response Card form via fax to BD at 1-201-847-6990 or email to Becky_Saggau@bd.com and return all affected products. Note: If you do not have any of the affected lots in your inventory, please complete the Recall Response Card form indicating you have (0) quantity and fax or email. The distributors were instructed to immediately examine your inventory and identify any product subject to this notification. In addition, if you have further distributed this product, please identify your customers and notify them at once of this notification. Complete the attached Recall Reply Form and FAX to Bard Access Systems, Inc. at 1-801-522-5674, or EMAIL to BASD.fieldaction@crbard.com. Even if you do not have any inventory of the affected syringe lots. Please direct any return requests and questions to our coordinator at 800-290-1689. If you have any questions or require assistance with the return of the recalled product and/or availability of replacement product, please contact BD Customer Service at 1-888-237-2762 option 3.

Device

Bard Access
  • Modelo / Serial
    Lot Numbers: REXE1224, REYD1858, REXE0422, REXE0501, REYD0765, REYE1330, REYE1453, REXE0428, REXE0469, 13GB3687, REXD1150, 13HB2925, REYD1851, REXD1127, REYD1730, REXE0436, REXD1121, REXE0504, REXD1122, REXD1480, REXE0488, REXD1105, REYE1981, REXD1100, REXD1512, REXE0416, REXE0423, REXD1424, REYD1853, REXE0442, REXD2228, REXE0506, REXE1249, REXE1244, 13GB5123, REXD2243, REXD2244, REXD2221, REXD1507, REXD1159, REXE0724, 13GB3809, 13GB9452, 13HB0439, REYE0422, REXE0432, REXE1238, REYD1734, REXD1437, REXE1227, REYE0567, REXE0443, REXE1228, REXD1426, REXE0502, REXE1248, REYD1746, REXD1499, REXD1489, REXE0414, REXD1134, 13SB2585, 13GB3742, 13HB0440, REYD1986, REYD0634, REXE0448, REXD1147, REYD0718, REXD2246, REXE1260, REYE0645, REXE0481, REXD1154, REYE1472, REXD1155, REXD2225, REXE1247, REXE1917, 13KB1321, REYD0709, REYD1414, REXD1442, REXE0430, REXE0484, REXD1140, REXE0580, REXD1449, REXE0699, 13GB4430, 13HB9983, 13GB4431, REYD1342, REXD1441, REXE0498, REXD1148, REXD1440, REXE0483, REXE1295, reyd0573, REXD2233, REYE1465, REXE0462, REYD0630, REYD1865, REYD1744, REXD1481, REXE0528, REXE0812, REXC1785, REYE1467, REYE0591, REYD1747, REXD1128, reyd0521, 13SB2581, 13GB3737, 13SB2582, 12GB0338A, 13SB2578, 13SB0587, REXE0444, REYE1349, REXE0452, REXE0427, REXE1240, 13GB5446, 13KB1324, 13GB6046, REYE0912, REYE0907, REXD1471, REXD1473, REXE0475, REXE0446, REXE1229, REXD1452, REYD1742, REXE1234, 13GB3736, REXD1509, 13GB3738, 13SB2579, 13GB3741, 13GB3744, REXE0323, REYF1101, REXE0464, REXD1478, REXE0445, REXE1221, REXE0447, REXD1153, REYE0440, REXE0465, REXE0489, REXE1257, REXD1139, REXD2237, REYE0566, REXE0503, REXD1418, REXD1158, REXD1496, REYD1346, REYD1419, REXD1466, REXE1243, REYD1743, REXC1788, REYE0443, REXD1143, REXD2241, REXD2240, REXE0479, REXE0480, REXE1252, REYE0589, REYD1745, REXD1156, REYD1869, REXD1492, REXD1132, REXD1485, REXE0421, 13HB3413, 13HB3992, 13FB1090, 13GB9453, 13GB3684, 13SB3169, 13GB3798, 13GB4432, 13GB3801, 13GB4429, REYE0782, REXE0435, REXE1232, REXD1125, REXE1169, REXE0545, REXE1311, REYD1840, REYE0553, REXE0470, REYE0554, REXD2223, REXE0482, REXD1505, REXD1470, REXE0458, REXE0543, REXD1497, REXC1861, REXE0524, REXE0525, REXE1291, REYE1312, REYE1435, REXE0438, REXE0473, REXE0544, REXD1417, REYD1400, REXD1490, REYE0919, REYE1314, REYE0778, REXD2234, REXE0449, REXE0450, REXE0451, REXD2235, REXE0536, REYE0776, REXD1486, REXE0431, REXE0472, REXE0471, REXE0546, REXE1219, REYD0750, REYD1721, REYE0556, REXD1502, REXD2222, REXE0499, REXE1226, REYE0916, REYE0915, REYE1318, REXD2238, REXD2239, REXE0493, REXE0494, REXE0492, REXE0491, REXE0813, REXE0540, REXE0490, REXE1268, REXD1464, REXD1463, REYD1846, REYE1442, REXE0329, REXE1231, REXE0728, REXE0460, REYE0913, REXE0420, REXE0522, REXE1298, REYE0771, REXD1484, REXE0453, REXE0533, REXE1299, REYE0910, REYE1970, REXD1453, REXD2245, REXE0500, REXE1261, REXD1119, REXD1501, REXE0413, REYE0909, REYE0768, REXD1488, REXE0326, REXE0415, REXE0527, REXE1434, REXD0772, REXE0425, REXE0495, REXE1264, REXD1112, REXE0060, 13HB6959, 13KB1325, 13SB2586, 13KB0543, 13FB1089, 13RB1247, 13GB3683, 13GB3799, 13KB1326, 13SB2584, 13GB3739, 13KB0542, 13GB3740, 13GB3802, 13KB0545, 13GB3804, 13GB0155, 13HB0438, 13FB2112, 13FB8861, 13GB3743, 13GB3808, 13SB0588, 13IB3041, 13GB3685, 13GB3686, 13FB8863, 13GB3806, 13GB3797, 13GB8905, 13HB0436, 13GB3794, 13GB3795, 13GB3735, 13GB3796, 13GB8906, 13GB4481, REXD2198, REXD2199, REYE1980, REXD2218, REXD2216, REXD2220, REXD2219, REYD1982, REYE1979, REYE1978, 13GB8904, 13SB0036, 13SB0585, REYD1407, REYE0439, REXE0017, REXD1465, 13SB2580, REXD1104, REYE1803. Product Codes: 4153108 4153108D, 4154108D, CK000119A, 7927508D, CK000050A, 3175108, 3175108D, 3153108, 3154108, 3255108, CK000108, CK000109, CK000110, 7617407, 7617408, 7617408D, 3275108, 3275108D, 3275108FD, CK000036, CK000057, CK000099, CK000111, CK000206, 3386108, 3385108Q, 3385108QD, 3386108D, 9385108Q, 9385108QD, CK000145A, CK000207, CK000293, 9617407, 9617408, 9827507, 9827508, 9617408d, 9827508d, CK000235, 9153108, 9154108, 9254108, 9255108, CK000150, CK000294, 9175108, 9275108, 9276108, 9175108d, 9275108d, 9275108F, 9386108d, 9386108QD, CK000021, CK000082, CK000134, CK000216, CK000218, 9818508, 9818508d, 9918508D, CK000204, CK000205, 3174108, 9174108, 3174108D, 9174108d, CK000080, CK000098, CK000143, CK000165A, CK000178, CK000214, CK000269, CK000335, 3194108, 3295108, 3396108, 9194108, 9295108, 3295108d, 3295108F, 3395108Q, 3395108QD, 3396108D, 9194108D, 9295108d, 9295108f, 9295108FD, 9395108Q, 9395108QD, CK000044, CK000061, CK000071A, CK000097, CK000137, CK000138, CK000201, CK000253, CK000245, 1174108, 1175108, 1194108, 1275108, 1295108, 1386108, 9396108, 1174108D, 1175108D, 1194108D, 1275108D, 1275108f, 1275108fd, 1295108D, 1295108f, 1295108fd, 1385108D, 1385108Q, 1385108QD, 1386108D, 1395108Q, 1395108QD, 1396108D, CK0000103, CK000025, CK000026A, CK000127, CK000128, CK000129, CK000142, CK000155, CK000169A, CK000184, CK000186, CK000187A, CK000188A, CK000191, CK000192, CK000194, CK000220, CK000221, CK000222, CK000228A, CK000231, CK000232, CK000233, CK000241, CK000242, CK000252, CK000266, CK000267, CK000268, CK000283, CK000287, CK000291, CK000295, CK000296, CK000297, 3173108, 9173108, 3274108D, 9274108D, CK000215
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution.
  • Descripción del producto
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline BARD MYPICC KIT (4F) (Single Lumen), Groshong NXT Catheter 5F Maximal Barrier Tray (Dual-Lumen) (with MicroIntroducer) , Groshong NXT BARD MYPICC KIT (5F) (Dual-Lumen) (45cm), PowerPICC Catheter 5F Full Tray (Single-Lumen), PowerPICC Catheter 5F Maximal Barrier Tray (Single-Lumen), Poly Per-Q-Cath Catheter 3F Single-Lumen Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter 4F Single-Lumen Full Tray (with Mircrointroducer), Poly Per-Q-Cath 5F Dual-Lumen Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter 3F Full Tray (Single-Lumen) (with Microintroducer) (60cm), Poly Per-Q-Cath Catheter 4F Full Tray (Single-Lumen) (with Microintroducer) (60cm), Poly Per-Q-Cath Catheter 5F Full Tray (Dual-Lumen) (with Microintroducer) (60cm), Groshong NXT ClearVue 4F Catheter Full Tray (Single-Lumen) (60cm), Groshong NXT ClearVue 4F Catheter Full Tray (Single-Lumen) (60cm) (with Microintroducer), Groshong NXT ClearVue Catheter 4F Maximal Barrier Tray (Single-Lumen), PowerPICC 5F Dual-Lumen Polyurethane Catheter with MicroEZ Microintroducer Nurse Full Tray (with Lidocaine), PowerPICC Catheter 5F Maximal Barrier Tray with Microintroducer (Dual-Lumen), PowerPICC FT Catheter 5F Maximal Barrier Tray Tray (Dual-Lumen), PowerPICC Bard MYPICC Kit 5F (Dual-Lumen)(with Nitinol Guidewire)(70cm), PowerPICC Catheter 5F Maximal Barrier Tray (Dual-Lumen) (55cm) (with Microintroducer), PowerPICC Catheter 5F Full Tray (Dual-Lumen) (70cm Nitinol Guidewire) (with Microintroducer), PowerPICC Bard MYPICC Kit 5F (Dual-Lumen) RN, PowerPICC BARD MYPICC KIT (5F) (Dual-Lumen), PowerPICC Catheter 6F Full Tray (Triple-Lumen)(with Microintroducer) (with Lidocaine), PowerPICC HF Catheter 5F Full Tray (Triple-Lumen), PowerPICC HF Catheter 5F Maximal Barrier Tray (Triple-Lumen), PowerPICC Catheter 6F (Triple-Lumen) Maximal Barrier Tray, PowerPICC SOLO HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Triple-Lumen), PowerPICC HF Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Triple-Lumen), PowerPICC HF Bard MYPICC Kit 5F (Triple-Lumen), PowerPICC HF BARD MYPICC KIT (5F) (Triple-Lumen), PowerPICC HF Catheter Maximal Barrier Tray (5F) (Triple-Lumen) (55cm), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (Single-Lumen), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (Single-Lumen) (with Microintroducer), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen) (45cm), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen) (45cm) (with Microintroducer), Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet 4F Maximal Barrier Tray (Single-Lumen), Groshong NXT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Maximal Barrier Tray (Dual-Lumen) (45cm), Groshong NXT Sherlock II BARD MYPICC KIT (4F) (Single-Lumen) (TLS), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 3F Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray (with Microintroducer), Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 4F Full Tray, Poly Per-Q-Cath Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray, Poly Per-Q-Cath Sherlock II Bard MYPICC KIT (4F) (Sinlge-Lumen) (TLS), Poly Per-Q-Cath Sherlock II BARD MYPICC KIT (4F) (Single-Lumen) (TLS), PowerPICC Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Single-Lumen) (with Microintroducer), PowerPICC 5F Dual-Lumen Polyurethane Catheter with Sherlock Tip L
  • Manufacturer
    Bard Access Systems

Manufacturer

Bard Access Systems
  • Dirección del fabricante
    Bard Access Systems, 605 N 5600 W, Salt Lake City UT 84116-3738
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA