Arrow International Recalls Select Kit Products Due to Molding Abnormality
Arrow International is recalling 6,121 units of Select Kit products due to a component molding abnormality reported by a supplier.
What this means for you
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 describes a packaging component molding abnormality without reporting any illnesses, injuries, or specific functional failures of the medical device itself, 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 after a supplier reported a component molding abnormality used to package these products. The affected products are described as intravascular therapeutic catheter access kits intended for long-term use (greater than 30 days) and contain no base components.
The recalled units were distributed in the United States to North Carolina, Ohio, Florida, and Maryland. The specific lot numbers involved in this recall are 23F15L0662, 23F15J0260, 23F15K0983, 23F15G0159, 23F15J1102, 23F15J0259, 23F15C1225, 23S15G0973, 23F15H1033, 23F15F0358, 23F15K0345, 23F15D1514, 23F15C1226, 23F15H0919, 23F15E1091, 23F15H0014, 23F15D0241, 23F15J0533, 23F15E1094, 23F15H0020, 23F15H0740, 23F15K1009, 23F15J0431, 23F15F1836, 23F15H0857, 23F15K0012, 23F15M0313, 23F15G0871, and 23F15J0285.
Healthcare providers and consumers should check their inventory for these specific lot numbers. If the products are found, they should be removed from use and returned to the manufacturer or the supplier from whom they were purchased. No specific instructions for patient management are provided in the source text.
The recalled product
- Product
- Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- 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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