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.
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 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
- 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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