Synovis VASCU-GUARD Peripheral Vascular Patch in the recall
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…
Why was Synovis VASCU-GUARD Peripheral Vascular Patch in the recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 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…
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 32,763 eaches UPDATE 9/1/2016 2,042 eaches
- Distribution
- 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.
- Recall date
- August 24, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)