Smiths Medical ASD Inc.: Medical Device Recall in 2019 - (Recall #: Z-0842-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 22, 2018

Date Posted: February 27, 2019

Recall Number: Z-0842-2019

Event ID: 80829

Reason for Recall:

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.

Status: Terminated

Product Quantity: Approx. 28,578,939 kits for both products

Code Information:

Product with expiration dates between 11/30/2016 and 5/31/2020.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated