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

Arrow International Recalls Multi-Lumen CVC Kits Due to Sterility Concerns

Arrow International Inc is recalling 416,055 ARROWgard Blue PLUS Multi-Lumen CVC Kits 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 is classified as FDA Class II. The hazard involves a medical device where sterility may be compromised, posing a risk of infection, which fits the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Arrow International Inc is recalling 416,055 units of the ARROWgard Blue PLUS Multi-Lumen CVC Kit with Blue FlexTip Catheter (Product Code: MSO-45703-AHS). The recall is being conducted because product sterility may be compromised due to unsealed packaging.

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 South America. The specific lot numbers involved are 13F17C0230, 13F17D0161, 13F17F0068, 13F17G0364, 13F17H0351, 13F17J0387, 13F17K0579, and 13F17L0487.

Healthcare facilities and distributors should stop using the affected lots and contact Arrow International Inc for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: ARROWgard Blue PLUS¿ Multi-Lumen CVC Kit with Blue FlexTip¿ Catheter; Product Code: MSO-45703-AHS
Manufacturer: Arrow International Inc
Category: Medical Device — Catheters
Hazard: infection
sterility-compromise
Affected units: 416,055

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