Arrow Arterial Catheterization Kits Recalled for Unsealed Packaging
Arrow International is recalling 416,055 Arterial 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 is compromised, creating 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 Arterial Catheterization Kits (Product Code: ASK-04020-DH). The recall is due to unsealed packaging, which may compromise the sterility of the product.
The affected products were distributed in the United States and 34 other countries, including Australia, Canada, and the United Kingdom. Specific lot numbers involved in the recall include 13F17B0307, 13F17D0070, 13F17E0417, 13F17G0012, 13F17G0508, 13F17H0421, 13F17L0155, and 13F17L0478.
Healthcare providers and consumers should check their inventory for these specific product codes and lot numbers. If the packaging is unsealed, the product should not be used. Users should contact Arrow International Inc for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Arterial Catheterization Kit; Product Codes: ASK-04020-DH
- 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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