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U.S. Department of Health and Human Services

Class 2 Device Recall Synovis VASCUGUARD Peripheral Vascular Patch

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  Class 2 Device Recall Synovis VASCUGUARD Peripheral Vascular Patch see related information
Date Initiated by Firm June 24, 2016
Create Date August 12, 2016
Recall Status1 Open3, Classified
Recall Number Z-2533-2016
Recall Event ID 74625
510(K)Number K983602  
Product Classification Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
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 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.
Code Information 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.



Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Baxter Product Surveillance
800-437-5176
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Under Investigation by firm
Action 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.
Quantity in Commerce 32,763 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.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DXZ and Original Applicant = BIO-VASCULAR, INC.
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