Arrow International Recalls Catheter Hemostasis Valves Due to Packaging Defect
Arrow International is recalling 416,055 catheter hemostasis valves because unsealed packaging may compromise product sterility.
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 the source text explicitly states that no illnesses or injuries have been reported. The hazard is theoretical (potential sterility compromise), which aligns with the rubric for a score of 2 (voluntary precautionary recall/low-risk contamination).
Plain-English summary
Arrow International Inc is recalling 416,055 units of the Catheter Hemostasis Valve (Product Code: AI-07000). The recall is due to a defect where product sterility may be compromised by unsealed packaging. The affected lots are 13F17C0232, 13F17G0194, 13F17H0047, and 13F17J0083.
The affected products were distributed in the United States and numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and the Americas. The source text does not specify the exact number of units distributed in each region.
Healthcare facilities and consumers should stop using the affected products and contact Arrow International Inc for further instructions or a return. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000
- Manufacturer
- Arrow International Inc
- Affected units
- 416,055
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)
- Lot Numbers: 13F17C0232 13F17G0194 13F17H0047 13F17J0083
Distribution
Part of a larger recall action
This product is one of 76 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 76 products in this recall →Related recalls
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