Exact FDA event identifier

Event 66763

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: October 28, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Synovis Surgical Innovations, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-0338-2014

Recall number: Z-0338-2014
Initiated: October 28, 2013
Classification: Class II
Status: Terminated
Recalling firm: Synovis Surgical Innovations, Inc.
Quantity: 6014 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

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

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

Distribution pattern

Nationwide Distribution.

device · product 2 of 2

Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery. Product Code: DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN

Z-0339-2014

Recall number: Z-0339-2014
Initiated: October 28, 2013
Classification: Class II
Status: Terminated
Recalling firm: Synovis Surgical Innovations, Inc.
Quantity: 446 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

Lot Numbers: SPCE113-03C0006 SPCE113-04D0002 SPCE113-04D0047 SPCE113-05E0052 SPCE113-05E0072 SPCE113-07G0077 SPCE113-08H0018 SPCE113-08H0073 SPCE113-03C0008 SPCE113-03C0072 SPCE113-04D0036 SPCE113-04D0092 SPCE113-04D0093 SPCE113-05E0047 SPCE113-05E0048 SPCE113-06F0053 SPCE113-06F0054 SPCE113-07G0008 SPCE113-07G0072 SPCE113-08H0016 SPCE113-FEB0092 SPCE113-JAN0046 SPCE113-JAN0106 SPCE113-03C0004 SPCE113-03C0069 SPCE113-03C0070 SPCE113-03C0071 SPCE113-04D0085 SPCE113-04D0086 SPCE113-05E0073 SPCE113-05E0074 SPCE113-06F0055 SPCE113-06F0057 SPCE113-06F0138 SPCE113-06F0139 SPCE113-07G0074 SPCE113-07G0075 SPCE113-08H0019 SPCE113-JAN0047 SPCE113-JAN0048 SPCE113-JAN0109 SPCE113-JAN0125

Distribution pattern

Nationwide Distribution.