Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1281-2018·Announced 2018-04-11

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.

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 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
Category: Medical Device — Catheterization Kits
Hazard: mis-labeling
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

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