TriMed Inc. recalls Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO;…

Recall date

January 11, 2018

Source

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

Recall number

Z-1373-2018

FDA classification

Class II

Brand / firm

TriMed Inc.

Sold / distributed

US, China, Latin America

Why it was recalled

Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.

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

What was recalled

Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO