medical Class II Updated 2019-02-27

Smiths Medical ASD Inc. recalls Aplicare Povidone Iodine Prep Pads packaged within Portex Pr

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product with expiration dates between 11/30/2016 and 5/31/2020.
View official government recall

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