DeRoyal Industries Inc recalls Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Should…

Recall date

January 22, 2018

Source

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

Recall number

Z-0637-2018

FDA classification

Class II

Brand / firm

DeRoyal Industries Inc

Sold / distributed

US Distribution to: NY

Why it was recalled

DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.

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

What was recalled

Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy