Arrow International Recalls Triple-Lumen CVC Kits Due to Packaging Defect
Arrow International is recalling 416,055 ARROWgard Blue PLUS Triple-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 medical device where sterility may be compromised, creating a risk of harm (infection) even though no injuries have been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Arrow International Inc is recalling 416,055 units of the ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter (Product Code: ASK-45703-VC). The recall was initiated 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. Specific lot numbers involved in the recall include 13F17A0219, 13F17C0013, 13F17C0431, 13F17D0166, 13F17F0070, 13F17F0714, 13F17G0590, 13F17J0392, and 13F17L0070.
Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected kits. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- 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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