Arrow International Recalls Echogenic Introducer Needles Due to Packaging Defect
Arrow International is recalling 416,055 Echogenic Introducer Needles because unsealed packaging may compromise product sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential loss of sterility in a medical device, which poses a risk of infection, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Echogenic Introducer Needles (Product Code: AN-04318). The recall was initiated because the product's sterility may be compromised due to unsealed packaging.
The affected products were distributed nationwide in the United States and in numerous international markets, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and the Middle East. The recall covers specific lot numbers, including 13F17A0231, 13F17B0321, and 13F17L0233.
Healthcare providers and consumers should check their inventory for the affected lot numbers and stop using the products if the packaging is unsealed. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Echogenic Introducer Needle; Product Code: AN-04318
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Needles
- Affected units
- 416,055
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.
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