Arrow International Recalls Pressure Injectable CVC Kits Due to Sterility Concerns
Arrow International is recalling 416,055 ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC 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 medical device where sterility may be compromised, creating a risk of infection. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling 416,055 units of ARROWg+ard Blue PLUS Pressure Injectable Quad-Lumen CVC Kits. The recall affects product codes CDC-42854-P1A and CDC-45854-P1A. The company identified that 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 the Middle East. Specific lot numbers for both product codes are listed in the official recall documentation.
Healthcare facilities and consumers should stop using these specific kits immediately. Users should contact Arrow International Inc for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
- Manufacturer
- Arrow International Inc
- 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.
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