Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1287-2018·Announced 2018-04-11

Arrow Arterial Access Tray Recall for Povidone Iodine Shelf Life Labeling

Arrow International is recalling Arterial Access Trays because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and must 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 source text identifies the issue as a shelf-life labeling discrepancy rather than a defect causing reported injuries or hospitalizations, fitting the criteria for a moderate severity labeling error.

Plain-English summary

Arrow International Inc is recalling 1,190 units of the Arterial Access Tray, introducer catheter, Model GU-04020. The recall is due to a labeling issue where the povidone iodine prep pads included in the kits 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 13F17A0292, 13F17C0309, 13F17E0359, 13F17G0300, 13F17J0242, 23F16F0623, and 23F16G0675, with expiration dates ranging from October 2018 through March 2020. These products were distributed nationwide in the United States, including Puerto Rico.

The FDA has classified this as a Class II recall. Healthcare facilities and consumers should check their inventory for these specific lot numbers and expiration dates. If found, the products should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product: Arterial Access Tray, introducer catheter; Model: GU-04020
Manufacturer: Arrow International Inc
Category: Medical Device — Surgical Kits
Hazard: mis-labeling
Affected units: 1,190

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 (8)

Lots: 13F17A0292
13F17C0309
13F17E0359
13F17G0300
13F17J0242
23F16F0623
23F16G0675
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