FDAFDA · Food and drugs·Recall number Z-1637-2015
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.
Published June 10, 2015 · Recall initiated: May 2, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synovis Surgical Innovations, Inc.
- Distributor
- Nationwide Distribution.
- Lot
- all lot numbers
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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