Events

Bard Access 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bard Access Systems 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    70430
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1271-2015
  • 사례 시작날짜
    2014-08-08
  • 사례 출판 날짜
    2015-03-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133596
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution.
  • 제품 설명
    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