Smiths Medical Recalls Arterial Blood Sampling Kits with Povidone Iodine Pads
Smiths Medical ASD Inc. is recalling arterial blood sampling kits because the included povidone iodine prep pads may not maintain potency through their expiration dates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a failure of potency rather than a direct injury or contamination event, fitting the criteria for a moderate risk of adverse health consequences.
Plain-English summary
Smiths Medical ASD Inc. is recalling Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kits with Dry Lithium Heparin for Gases and Electrolytes. The recall affects approximately 28,578,939 kits with expiration dates between November 30, 2016, and May 31, 2020.
The recall is being conducted because the povidone iodine prep pads packaged with the kits will not maintain the iodine potency through their labeled 36-month expiration dating. This issue affects the efficacy of the antiseptic pads used for skin preparation prior to arterial blood sampling.
Distribution was nationwide, including Puerto Rico, as well as military/government distribution. Foreign distribution was made to Canada, the United Arab Emirates, the Bahamas, Costa Rica, Latvia, and Saudi Arabia. Affected models include 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. Users should stop using the affected kits and contact Smiths Medical ASD Inc. for further instructions.
The recalled product
- 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,
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- Affected units
- 28,578,939
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product with expiration dates between 11/30/2016 and 5/31/2020.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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