Z-1637-2015 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2015
- Initiation Date
- May 2, 2015
- Termination Date
- February 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,974
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.
Distribution Pattern
Nationwide Distribution.
Code Information
all lot numbers