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.
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 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.
- Manufacturer
- Arrow International Inc
- Hazard
- 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
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.
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