Events

Device Recall Synovis VASCUGUARD Peripheral Vascular Patch 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corp. 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
    74625
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2533-2016
  • 사례 시작날짜
    2016-06-24
  • 사례 출판 날짜
    2016-08-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148062
  • 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
    Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
  • 원인
    Baxter is issuing a safety alert in response to postmarketing reports received for the vasc u-guard peripheral vascular patch. baxter has received reports for intraoperative or postoperative bleeding episodes, which required additional clinical intervention. one report involved a case with a fatal outcome. update 9/1/2016 baxter issued a notice retrieving 6 lots of vascu-guard due to the increased postmarketing reports related to intraoperative and postoperative bleeding.
  • 조치
    Baxter sent a Safety Alert to customers via USPS overnight delivery beginning 6/24/2016. The letter told of the reported adverse events, asked for product that product immediately be discontinued from use, to segregate/quarantine all affected lots, and to return the enclosed customer reply form. General questions regarding the Safety Alert should be directed to Baxter Product Surveillance at 1-800-437-5176, between 8:00 am - 5:00 pm Central Time Monday thru Friday. Clinical inquiries can be directed to Baxter's Medical information at 1-800-933-0303, Monday thru Friday 8:00 am - 5:00 pm central time. UPDATE 9/1/2016 Baxter issued an Urgent Product Recall letter beginning 9/1/2016. This letter explained the issue and identified affected product that was to be removed from the consignee and returned to Baxter. Customer is to contact Baxter Healthcare Center for Service to arrange for return and credit. This can be done at 888-229-0001 Monday thru Friday 7:00 am - 6:00 pm Central Time. General questions regarding the recall can be addressed to Baxter Product Surveillance at 800-437-5179 Monday thru Friday, 8:00 am - 5:00 pm Central Time.

Device

Device Recall Synovis VASCUGUARD Peripheral Vascular Patch
  • 모델명 / 제조번호(시리얼번호)
    Product Code VG0106N, Lot #: SP16A04-1108933, SP16A11-1111696, SP16A12-1111933, SP16A12-1111938, SP16A12-1111942, SP16A12-1111947, SP16A27-1116312, SP16A29-1116884, SP16B04-1118465, SP16B08-1119650, SP16B12-1121361, SP16B22-1123979, SP16B24-1124658, SP16C01-1126439, SP16C01-1126508, SP16C07-1128790, SP16C08-1129067, SP16C09-1129905, SP16C10-1130129, SP16C10-1130134, SP16C23-1134739, SP16C28-1136324, SP16C28-1136332, SP16D06-1139370, SP16D13-1141301, SP16D19-1142941, SP16D20-1143649, SP16D20-1143655, SP16D21-1143852, SP16D28-1146476, SP16E04-1148533, SP16E04-1148534, SP16E19-1152299, SP16E24-1153675, SP16F01-1155425, SP16F01-1155678, SP16F01-1155682, SP16F01-1155685.   Product Code VG0108N, Lot #: SP16A04-1108941, SP16A04-1108956, SP16A04-1108974, SP16A06-1110391, SP16A12-1111872, SP16A12-1111952, SP16A14-1112703, SP16A14-1112720, SP16A18-1113372, SP16A19-1114051, SP16A19-1114056, SP16A21-1114800, SP16A21-1114802, SP16A21-1114805, SP16B04-1118471, SP16B04-1118475, SP16B05-1119212, SP16B05-1119217, SP16B08-1119654, SP16B08-1119720, SP16B12-1121365, SP16B12-1121366, SP16B19-1123365, SP16B22-1123983, SP16B25-1125254, SP16B25-1125260, SP16B25-1125268, SP16C01-1126459, SP16C07-1128755, SP16C08-1129301, SP16C10-1130184, SP16C10-1130191, SP16C10-1130200, SP16C10-1130208, SP16C10-1130219, SP16C10-1130227, SP16C16-1132096, SP16C18-1133115, SP16C18-1133138, SP16C18-1133148, SP16C18-1133152, SP16C18-1133155, SP16C18-1133157, SP16C21-1133807, SP16C22-1134481, SP16C24-1135156, SP16C28-1136307, SP16C28-1136436, SP16D01-1137764, SP16D04-1138414, SP16D04-1138417, SP16D12-1140707, SP16D12-1140708, SP16D19-1142958, SP16D19-1142967, SP16D21-1143872, SP16D21-1143878, SP16D28-1146462, SP16D28-1146466, SP16D28-1146471, SP16E04-1148520, SP16E04-1148522, SP16E04-1148549, SP16E05-1148667, SP16E11-1150104, SP16E11-1150110, SP16E11-1150115, SP16E11-1150174, SP16E19-1152326, SP16E19-1152330, SP16E19-1152335, SP16E24-1153278, SP16E24-1153280, SP16E26-1154142, SP16E26-1154146, SP16E27-1154532, SP16E27-1154534, SP16F01-1155407, SP16F07-1157497, SP16F07-1157505, SP16F07-1157513.   Product Code VG0110N, Lot #: SP16A12-1111926, SP16A12-1111931, SP16A20-1114346, SP16B22-1123992, SP16C08-1129312, SP16C08-1129329, SP16C09-1129911, SP16C25-1135841, SP16D11-1140274, SP16D11-1140284, SP16D20-1143641, SP16D20-1143643, SP16D25-1144838, SP16E11-1150202, SP16F07-1157244, SP16F07-1157253, SP16F07-1157260.   Product Code VG0209N, Lot #: SP16A04-1108918, SP16A12-1112283, SP16A12-1112284, SP16A20-1114352, SP16A21-1114790, SP16B15-1121467, SP16B22-1124000, SP16B25-1125139, SP16C08-1129339, SP16C08-1129346, SP16C14-1131192, SP16C16-1132144, SP16D01-1137778, SP16D11-1140290, SP16D18-1142652, SP16D20-1143633, SP16D20-1143638, SP16D28-1146487, SP16D28-1146606, SP16E04-1148530, SP16E11-1150205, SP16E19-1152309, SP16E27-1154668, SP16E27-1154693, SP16F08-1157871.   UPDATE 9/1/2016 the following lots are being retrieved for return to Baxter: Product Code VG0106N: Lot #: SP16C09-1129905. Product Code VG0108N: Lot #: SP16B08-1119720, SP16C18-1133152, SP16D04-1138417, SP16D28-1146462, SP16E04-1148522.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide including Puerto Rico, and outside the US to include: Australia, Austria, Finland, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Poland, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, United Kingdom.
  • 제품 설명
    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: || 1 cm x 6 cm, product code VG0106N, || 0.8 cm x 8 cm, product code VG0108N, || 1 cm x 10 cm, product code VG0110N, and || 2 cm x 9 cm, product code VG0209N. || VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. || UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: || 1 cm x 6 cm, product code VG0106N, || 0.8 cm x 8 cm, product code VG0108N.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • 제조사 주소
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA