Centurion Medical Products Corporation recalls Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)

Recall date

October 23, 2014

Source

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

Recall number

Z-0945-2015

FDA classification

Class II

Brand / firm

Centurion Medical Products Corporation

Sold / distributed

Nationwide Distribution including MA, IN, NY, GA, AL, PA, and RI.

Why it was recalled

According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.

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

What was recalled

Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)