Arrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Concerns
Arrow International is recalling 416,055 Percutaneous Sheath Introducer 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a theoretical risk of compromised sterility due to packaging issues without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Percutaneous Sheath Introducer Kits with ARROWgard Blue Sheath and Integral Hemostasis Valve/Side Port. The affected products are designated for use with 7 - 7.5 Fr. Catheters and include product codes MSO-29802-AHS and MSO-29903-AHS.
The recall was initiated because product sterility may be compromised due to unsealed packaging. The agency has classified this as a Class II recall. The products were distributed in the United States and numerous international locations, including Australia, Canada, the United Kingdom, and various countries in Europe, Asia, and the Americas.
Specific lot numbers affected include 13F17C0408, 13F17E0419, 13F17F0683, 13F17H0283, and 13F17K0545 for product code MSO-29802-AHS, and 13F17E0607, 13F17G0356, 13F17K0327, and 13F17L0350 for product code MSO-29903-AHS. Healthcare facilities and distributors should stop using these products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903-AHS
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Vascular Access
- 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.
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