Arrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Issues
Arrow International is recalling 416,055 Percutaneous Sheath Introducer Kits because unsealed packaging may compromise sterility. The recall covers products distributed in the US and 34 other countries.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a theoretical risk of compromised sterility due to packaging, which aligns with the criteria for a moderate severity score.
Plain-English summary
Arrow International Inc is recalling 416,055 units of Percutaneous Sheath Introducer Kits with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters (Product Code: ASK-09903-UPA). The recall is due to a risk that product sterility may be compromised by unsealed packaging.
The affected products were distributed nationwide in the United States and internationally in Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Ecuador, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Panama, Philippines, Poland, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, and the United Kingdom. The specific lot numbers involved are 13F17E0762, 13F17F0599, 13F17H0058, 13F17J0241, 13F17L0114, and 13F17L0485.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected kits. Consumers and patients should contact their healthcare provider if they have had a procedure using these products to discuss any concerns.
The recalled product
- Product
- Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-09903-UPA
- Manufacturer
- Arrow International Inc
- 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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