Arrow Select Kit Recall Due to Component Molding Abnormality
Arrow International Inc. is recalling 6,121 Arrow Select Kit units due to a component molding abnormality reported by a supplier.
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 source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Arrow International Inc. is recalling 6,121 units of Arrow Select Kit (ASK) products. The recall was initiated following a notification from a supplier regarding a component molding abnormality used in the packaging of these products.
The affected products are Arrow Select Kits, which are indicated to provide short-term central venous access for less than 30 days. The recall covers specific lot numbers distributed to North Carolina, Ohio, Florida, and Maryland.
Consumers and healthcare providers should stop using the affected Arrow Select Kit products and contact Arrow International Inc. for further instructions or a replacement.
The recalled product
- Product
- Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 6,121
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 (20)
- Lot/Batch Numbers: 23F15L0662
- 23F15J0260
- 23F15K0983
- 23F15G0159
- 23F15J1102
- 23F15J0259 23F15C1225
- 23S15G0973
- 23F15H1033
- 23F15F0358
- 23F15K0345
- 23F15D1514 23F15C1226
- 23F15H0919
- 23F15E1091
- 23F15H0014
- 23F15D0241
- 23F15J0533 23F15E1094
- 23F15H0020
- 23F15H0740
- 23F15K1009
- 23F15J0431
Distribution
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
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