DeRoyal Industries Inc recalls DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplica…

Recall date

December 19, 2017

Source

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

Recall number

Z-0334-2018

FDA classification

Class II

Brand / firm

DeRoyal Industries Inc

Sold / distributed

Distributed to states of: CA and MO.

Why it was recalled

DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.

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 kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack 89-8687.01 (d) Knee Arthro Pack 89-8687.02 Product Usage: general surgical