Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling
Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement.
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 and involves a labeling error regarding shelf life, which aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Arrow International Inc is recalling 50,263 units of Radial Artery Catheterization Kits, Model AK-04020. The recall is due to a labeling issue where the povidone iodine prep pads included in the kits do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
The affected products were distributed nationwide in the United States, including Puerto Rico. The recall covers specific lots with expiration dates ranging from October 2018 through March 2020. The agency has classified this as a Class II recall.
Healthcare providers and consumers should stop using the affected kits and contact Arrow International Inc for further instructions or a replacement.
The recalled product
- Product
- Radial Artery Catheterization Kit; Model: AK-04020
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 50,263
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 (15)
- Lots: 13F16H0263
- 13F16J0335
- 13F16K0145
- 13F16M0246
- 13F17C0500
- 13F17F0199
- 13F17F0473
- 13F17F0530
- 13F17G0325
- 23F16E1189
- 23F16E1190
- 23F16F0474
- 23F16F1041
- 23F16H0164
- Expiration dates: October 2018 through March 2020
Distribution
Part of a larger recall action
This product is one of 7 recalled by Arrow International 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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