Smiths Medical ASD Inc.: Medical Device Recall in 2019 - (Recall #: Z-0843-2019)

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 Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 4084P-1, G1193, G1374, G1585, G1589, G1598, G1621, and G1806. 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-0843-2019

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