Arrow International Recalls Central Venous Catheter Kits Due to Sterility Concerns
Arrow International Inc is recalling 416,055 ARROWg+ard Blue PLUS Multi-Lumen 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 medical device where sterility may be compromised, posing a risk of infection. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Arrow International Inc is recalling 416,055 units of the ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit, Product Code ASK-42703-SJH. The recall is due to a potential compromise in product sterility caused by unsealed packaging.
The affected products are distributed in the United States and numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and the Americas. The specific lot numbers involved in this recall are 13F17E0547, 13F17F0680, 13F17G0214, 13F17J0347, and 13F17L0150.
Healthcare facilities and distributors should check their inventory for these specific lot numbers and stop using the affected kits. Consumers and medical professionals should contact Arrow International Inc for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 416,055
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 13F17E0547 13F17F0680 13F17G0214 13F17J0347 13F17L0150
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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