The Recall Desk
ModerateFDA (Devices)·Z-2741-2016·Announced 2016-09-14

Arrow Radial Artery Catheterization Kits Recalled for Shipping Labeling Error

Arrow International Inc. is recalling 690 Radial Artery Catheterization Kits due to a shipping carton labeling error. The kits were distributed to Ohio, Indiana, Tennessee, North Carolina, and Kentucky.

What this means for you

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 specific cause as a 'shipping carton labeling error' with no mention of reported injuries, illnesses, or functional device defects. This aligns with the rubric for minor labeling errors or low-risk issues.

Plain-English summary

Arrow International Inc. is recalling 690 Radial Artery Catheterization Kits with Sharps Safety Features. The recall was initiated because of a shipping carton labeling error. The device is intended to permit access to the peripheral arterial circulation, with a safety feature designed to help minimize the risk of sharps injuries.

The affected kits were distributed nationwide to facilities in Ohio, Indiana, Tennessee, North Carolina, and Kentucky. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.

Healthcare facilities and consumers who have these kits should stop using them and contact Arrow International Inc. for instructions on how to return or dispose of the product. The recall number is Z-2741-2016.

The recalled product

Product
Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
Affected units
690

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 (1)

  • Device Listing # D025180

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →