DeRoyal Industries Inc recalls DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09E…

Recall date

August 31, 2015

Source

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

Recall number

Z-0240-2016

FDA classification

Class II

Brand / firm

DeRoyal Industries Inc

Sold / distributed

SC, FL, OH, NJ, OK, MN, AR

Why it was recalled

Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.

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

What was recalled

DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01; TOTAL JOINT, REF 50-12160.17; BACK TRAY, REF 50-12602.09; PACEMAKER PACK, REF 89-8381.01;