Recall Z-1637-2015— Synovis Surgical Innovations, Inc.

Name: FDA recall Z-1637-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-02

Class I · Terminated

Class I FDA medical device recall by Synovis Surgical Innovations, Inc., initiated 2015-05-02, terminated 2016-02-18. It names one FDA 510(k) clearance: K142461. Product: Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.. Reason: Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface..

Recalling firm: Synovis Surgical Innovations, Inc.
Classification: Class I
Status: Terminated
Initiated: 2015-05-02
Terminated: 2016-02-18
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K142461 — VASCU-GUARD Peripheral Vascular PatchSynovis Life Technologies, Inc.·cleared 2014-11-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.

Reason for recall

Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface.

Data sourced from openFDA. This site is unofficial and independent of the FDA.