Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1284-2018·Announced 2018-04-11

Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

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 defect is a labeling error regarding shelf life rather than a direct contamination or structural defect, fitting the criteria for moderate severity involving minor labeling errors.

Plain-English summary

Arrow International Inc is recalling 2,491 units of Radial Artery Catheterization Kits, Model AK-04120. The recall is due to a labeling error regarding the shelf life of the povidone iodine prep pads included in the kits. These pads do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

The affected lots are 13F16H0289, 13F16M0161, 13F17E0858, 13F17G0178, 23F16E1191, and 23F16H0163. The expiration dates for these lots range from October 2018 through March 2020. The products were distributed nationwide in the United States, including Puerto Rico.

This is a Class II recall, which means the product may cause temporary or medically reversible health consequences. Consumers and healthcare providers should stop using the affected kits and contact Arrow International Inc for further instructions.

The recalled product

Product: Radial Artery Catheterization Kit; Model: AK-04120
Manufacturer: Arrow International Inc
Category: Medical Device — Catheterization Kits
Hazard: mis-labeling
Affected units: 2,491

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 (7)

Lots: 13F16H0289
13F16M0161
13F17E0858
13F17G0178
23F16E1191
23F16H0163
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