Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error
Arrow International is recalling 930 Radial Artery Catheterization Kits because the included povidone iodine prep pads are labeled with an incorrect 36-month shelf life instead of 24 months.
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 minor labeling error regarding shelf life, which fits the rubric criteria for Moderate severity (minor labeling errors, voluntary precautionary recalls).
Plain-English summary
Arrow International Inc. is recalling 930 units of the Radial Artery Catheterization Kit, Model AK-04018. The recall affects kits distributed nationwide in the United States, including Puerto Rico. The specific lots involved are 13F16H0183, 13F17E0728, 13F17F0525, 23F16E1188, and 23F16H0911, with expiration dates ranging from October 2018 through March 2020.
The reason for the recall is that the povidone iodine prep pads included in these kits do not meet the requirements for a 36-month shelf life. The pads should have been labeled with a 24-month shelf life. This is a labeling discrepancy regarding the expiration of the antiseptic component.
Healthcare facilities and consumers who have these specific kits should stop using them and contact Arrow International Inc. for further instructions or a return. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Radial Artery Catheterization Kit; Model: AK-04018
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 930
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 (6)
- Lots: 13F16H0183
- 13F17E0728
- 13F17F0525
- 23F16E1188
- 23F16H0911
- 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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