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 and should be labeled with a 24-month shelf life.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 specific hazard is a labeling error regarding shelf life without reported injuries or illnesses, fitting the 'Minor labeling errors' criterion for a Moderate severity score.
Plain-English summary
Arrow International Inc is recalling 6,358 units of Radial Artery Catheterization Kits, Model AK-04220. The recall involves specific lots with expiration dates ranging from October 2018 through March 2020. The products were distributed nationwide in the United States, including Puerto Rico.
The recall was initiated because the povidone iodine prep pads included in these kits do not meet the requirements for a 36-month shelf life. The source text states that these pads should be labeled with a 24-month shelf life instead. This is a labeling and shelf-life discrepancy regarding the included components.
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 affected lots are 13F16H0429, 13F16M0214, 13F17F0281, 23F16H0161, and 23F16J0018.
The recalled product
- Product
- Radial Artery Catheterization Kit; Model: AK-04220
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 6,358
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: 13F16H0429
- 13F16M0214
- 13F17F0281
- 23F16H0161
- 23F16J0018
- 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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