Z-0843-2019 Class II Terminated
FDA device recall Z-0843-2019 was initiated by Smiths Medical ASD Inc. on Jun 22, 2018 and is designated Class II. 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. The recall status is terminated (terminated Oct 5, 2020). Affected quantity: Approx. 28,578,939 kits for both products.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 27, 2019
- Initiation Date
- Jun 22, 2018
- Termination Date
- Oct 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Approx. 28,578,939 kits for both products
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.
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.
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.
Code Information
Product with expiration dates between 11/30/2016 and 5/31/2020.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0843-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026