FDA recall Z-1860-2020

Product

Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease

Reason for recall

Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Dubai, Argentina, Austria, Belgium, Brazil, Japan, Canada, China, Germany, Spain, Finland, France, UK, Hongkong, Italy, Korea, Netherlands, Poland, Serbia, Sweden.

Key facts

Status

Terminated

Initiation date

2020-04-07

Report date

2020-05-13

Termination date

2021-11-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1860-2020