Medline Laceration Tray recalled over laceration hazard

Recall date

September 21, 2017

Source

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

Official notice title

Medline Industries Inc recalls Medline Laceration Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093

Recall number

D-0279-2018

FDA classification

Class II

Brand / firm

Medline Industries Inc

Sold / distributed

Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

Why it was recalled

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

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

What was recalled

Medline Laceration Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093