Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1285-2018·Announced 2018-04-11

Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

Arrow International is recalling 570 Radial Artery Catheterization Kits because the included povidone iodine prep pads are labeled with an incorrect 36-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 and involves a labeling error regarding shelf life. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity category.

Plain-English summary

Arrow International Inc is recalling 570 units of the Radial Artery Catheterization Kit, Model AK-04122. The recall affects lots 13F16H0329, 13F17F0074, and 13F17G0237, with expiration dates ranging from October 2018 through March 2020. These 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 pads should have been labeled with a 24-month shelf life instead. This is a labeling discrepancy regarding the expiration of the antiseptic components within the kit.

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, in most cases, cause temporary or medically reversible health consequences.

The recalled product

Product: Radial Artery Catheterization Kit; Model: AK-04122
Manufacturer: Arrow International Inc
Category: Medical Device — Catheterization Kit
Hazard: mis-labeling
shelf-life
Affected units: 570

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 (4)

Lots: 13F16H0329
13F17F0074
13F17G0237
Expiration dates: October 2018 through March 2020

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 7 products in this recall →

Same manufacturer · Arrow International Inc

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Same hazard · mis labeling