| Date Initiated by Firm |
October 28, 2013 |
| Date Posted |
November 18, 2013 |
| Recall Status1 |
Terminated 3 on June 03, 2014 |
| Recall Number |
Z-0338-2014 |
| Recall Event ID |
66763 |
| 510(K)Number |
K983602
|
| Product Classification |
Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
|
| Product |
Vascu Guard, Peripheral Vascular Patch with Apex Processing.
For use in peripheral vascular reconstruction.
Product Code:
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0106N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0108N
VG0110N
VG0110N
VG0110N
VG0110N
VG0110N
VG0110N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
VG0209N
|
| Code Information |
Lot Numbers: SPCE113-03C0009 SPCE113-03C0067 SPCE113-03C0082 SPCE113-04D0001 SPCE113-04D0003 SPCE113-04D0028 SPCE113-04D0107 SPCE113-05E0032 SPCE113-05E0040 SPCE113-05E0065 SPCE113-05E0092 SPCE113-06F0001 SPCE113-06F0070 SPCE113-06F0071 SPCE113-06F0132 SPCE113-07G0001 SPCE113-07G0047 SPCE113-07G0099 SPCE113-07G0100 SPCE113-07G0116 SPCE113-08H0026 SPCE113-08H0057 SPCE113-FEB0002 SPCE113-FEB0029 SPCE113-JAN0091 SPCE113-JAN0092 SPCE113-JAN0099 SPCE113-JAN0104 SPCE113-JAN0133 SPCE113-03C0001 SPCE113-03C0002 SPCE113-03C0003 SPCE113-03C0022 SPCE113-03C0023 SPCE113-03C0024 SPCE113-03C0047 SPCE113-03C0062 SPCE113-03C0063 SPCE113-03C0064 SPCE113-03C0079 SPCE113-03C0080 SPCE113-03C0081 SPCE113-04D0020 SPCE113-04D0021 SPCE113-04D0032 SPCE113-04D0053 SPCE113-04D0054 SPCE113-04D0063 SPCE113-04D0098 SPCE113-04D0099 SPCE113-04D0108 SPCE113-04D0109 SPCE113-05E0029 SPCE113-05E0030 SPCE113-05E0031 SPCE113-05E0038 SPCE113-05E0039 SPCE113-05E0051 SPCE113-05E0054 SPCE113-05E0066 SPCE113-05E0080 SPCE113-05E0081 SPCE113-05E0082 SPCE113-05E0089 SPCE113-05E0093 SPCE113-06F0023 SPCE113-06F0058 SPCE113-06F0063 SPCE113-06F0064 SPCE113-06F0072 SPCE113-06F0073 SPCE113-06F0129 SPCE113-06F0130 SPCE113-06F0131 SPCE113-07G0003 SPCE113-07G0004 SPCE113-07G0016 SPCE113-07G0041 SPCE113-07G0042 SPCE113-07G0043 SPCE113-07G0044 SPCE113-07G0078 SPCE113-07G0079 SPCE113-07G0095 SPCE113-07G0103 SPCE113-07G0104 SPCE113-07G0111 SPCE113-07G0117 SPCE113-08H0034 SPCE113-08H0053 SPCE113-08H0054 SPCE113-08H0055 SPCE113-08H0056 SPCE113-08H0066 SPCE113-08H0067 SPCE113-08H0068 SPCE113-08H0069 SPCE113-08H0070 SPCE113-08H0081 SPCE113-09I0003 SPCE113-09I0012 SPCE113-09I0021 SPCE113-FEB0006 SPCE113-FEB0007 SPCE113-FEB0031 SPCE113-FEB0032 SPCE113-FEB0062 SPCE113-FEB0063 SPCE113-FEB0064 SPCE113-FEB0065 SPCE113-FEB0066 SPCE113-FEB0074 SPCE113-FEB0076 SPCE113-FEB0077 SPCE113-FEB0078 SPCE113-FEB0104 SPCE113-JAN0035 SPCE113-JAN0086 SPCE113-JAN0087 SPCE113-JAN0089 SPCE113-JAN0090 SPCE113-JAN0093 SPCE113-JAN0101 SPCE113-JAN0102 SPCE113-JAN0103 SPCE113-JAN0119 SPCE113-JAN0120 SPCE113-JAN0134 SPCE113-04D0004 SPCE113-05E0036 SPCE113-05E0037 SPCE113-07G0046 SPCE113-FEB0058 SPCE113-JAN0040 SPCE113-03C0025 SPCE113-03C0026 SPCE113-03C0027 SPCE113-03C0065 SPCE113-03C0066 SPCE113-04D0073 SPCE113-04D0074 SPCE113-04D0111 SPCE113-05E0053 SPCE113-05E0055 SPCE113-05E0067 SPCE113-06F0002 SPCE113-06F0060 SPCE113-06F0074 SPCE113-07G0002 SPCE113-07G0081 SPCE113-07G0083 SPCE113-08H0012 SPCE113-08H0065 SPCE113-FEB0046 SPCE113-FEB0067 SPCE113-FEB0068 SPCE113-FEB0069 SPCE113-JAN0088 SPCE113-JAN0100 |
Recalling Firm/
Manufacturer |
Synovis Surgical Innovations, Inc.
2575 University Ave W
Saint Paul MN 55114-1073
|
| For Additional Information Contact |
651-796-7300
|
Manufacturer Reason
for Recall |
Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the Instructions for Use (IFU) shipped in a divided cell shipping
|
FDA Determined
Cause 2 |
Packaging change control |
| Action |
A customer notification letter dated 10/28/13 was sent to all customers who purchased the Vascu Guard and the Dura Guard. The letter informs the customers of the problem identified and the actions to be taken. Customers with any questions regarding the recall are instructed to contact Customer Service unit at (800) 423-2090. If customers are distributors or if they have have distributed the recalled products to any other health care provider, they are instructed to notify their accounts and provide them with a copy of the recall notification. If customers would like Baxter to perform the recall task for them, then they are instructed to contact Stericycle at 1-866-912-8417. |
| Quantity in Commerce |
6014 units |
| Distribution |
Nationwide Distribution. |
| 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = DXZ and Original Applicant = BIO-VASCULAR, INC.
|
