Arrow International Recalls Multi-Lumen CVC Kits Due to Packaging Issues
Arrow International is recalling specific lots of ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kits because unsealed packaging may compromise 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 risk-of-harm product (compromised sterility of a medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Arrow International Inc is recalling 416,055 units of ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kits. The recall involves specific product codes and lot numbers distributed in the United States and numerous international markets, including Australia, Canada, and the United Kingdom.
The recall was initiated because product sterility may be compromised due to unsealed packaging. This defect could potentially affect the safety of the medical devices if used in clinical settings.
Healthcare facilities and distributors should check their inventory for the specific product codes and lot numbers listed in the recall notice. If the affected products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-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.
See all 76 products in this recall →Related recalls
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