Bard Medical Division recalls Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads a…

Recall date

March 21, 2018

Source

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

Recall number

Z-2943-2018

FDA classification

Class II

Brand / firm

Bard Medical Division

Sold / distributed

AR, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, SC, TN, TX, UT, and WA,

Why it was recalled

Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iodine assay level requirements to support 36 month expiration dating.

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

What was recalled

Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label.