Arrow International Recalls Continuous Nerve Block Needles Due to Packaging Defect
Arrow International is recalling 416,055 continuous nerve block 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 involves a medical device where sterility is compromised, posing a risk of infection (risk-of-harm product), but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Continuous Nerve Block Needles. The recall affects specific product codes including AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, and AB-18110-N. The products were distributed in the United States and numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and South America.
The recall was initiated because the product sterility may be compromised due to unsealed packaging. This defect poses a risk of infection if the needles are used. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare providers and consumers should stop using the affected needles and contact Arrow International Inc for further instructions or a return. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Continuous Nerve Block Needle; Product Codes: AB-00090, AB-00150, AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18080-N, AB-18110-N
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Needles
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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