Smiths Medical ASD Inc. recalls Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin…

Recall date

June 22, 2018

Source

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

Recall number

Z-0842-2019

FDA classification

Class II

Brand / firm

Smiths Medical ASD Inc.

Sold / distributed

Distribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, United Arab Emirates, Bahamas, Costa Rica, Latvia, and Saudi Arabia.

Why it was recalled

The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 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

Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH, 4699P-1, G1325, G1412, G1481, G1509, G1548, G1581, G1586, G1602, G1627, G1632, G1634, G1671, G1675, G1716, G1724, G1773, and G1807. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.