Arrow International Recalls Echogenic Needles Due to Packaging Sterility Concerns
Arrow International is recalling 416,055 echogenic needles because unsealed packaging may compromise product sterility. The recall covers products distributed in the US and 34 other countries.
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 does not report any illnesses, injuries, or hospitalizations. The hazard is a theoretical risk of compromised sterility due to packaging, which aligns with the rubric for moderate severity.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Echogenic Needles (product codes PN-00215-E and PN-00217-E) due to a potential sterility issue. The recall is being conducted because product sterility may be compromised due to unsealed packaging.
The affected products were distributed nationwide in the United States and in 34 other countries, including Australia, Canada, the United Kingdom, and Germany. Specific lot numbers for the recalled product codes are listed in the agency's official recall record.
Healthcare providers and consumers should stop using the affected needles and contact Arrow International Inc for further instructions or a return. This recall is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Echogenic Needle; Product codes: PN-00215-E and PN-00217-E
- 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.
See all 76 products in this recall →Related recalls
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