The Recall Desk
HighFDA (Devices)·Z-1985-2018·Announced 2018-06-06

Arrow Central Venous Catheterization Kit Recalled for Unsealed Packaging

Arrow International Inc. is recalling ARROWg+ard Blue Central Venous Catheterization Kits 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 high-risk medical device where sterility may be compromised, posing a risk of harm, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Arrow International Inc. is recalling ARROWg+ard Blue(R) Central Venous Catheterization Kits, product codes ASK-24306-WHC1 and ASK-24306-WHC2. The recall involves 416,055 total products distributed in the United States and 33 other countries and territories, including Australia, Canada, and the United Kingdom.

The recall was initiated because product sterility may be compromised due to unsealed packaging. The affected lot numbers are 13F17B0024, 13F17E0019, 13F17E0673, 13F17J0236, and 13F17L0497.

Healthcare facilities and distributors should stop using the affected products and contact Arrow International Inc. for further instructions. Consumers should not use these products if they have them in their possession.

The recalled product

Product
ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
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 →