Agency classClass IIOur severity:High FDA (Devices)·Z-1958-2018·Announced 2018-06-06

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.

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 3/5 (High).

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
Hazard: infection
sterility-compromise

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Same manufacturer · Arrow International Inc

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Same hazard · infection