Genesee BioMedical, Inc. recalls Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 an…

Recall date

February 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1953-2018

FDA classification

Class II

Brand / firm

Genesee BioMedical, Inc.

Sold / distributed

Worldwide distribution. US nationwide, South Korea, Australia, COSTA RICA, Taiwan, New Zealand, Italy, Canada, Netherlands, Norway, Sweden, Switzerland, Israel, Japan, Egypt, South Africa, United Kingdom

Why it was recalled

Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.