Arrow Single-Lumen Catheters Recalled for Packaging Component Molding Abnormality
Arrow International Inc. is recalling 6,121 units of Arrow Single-Lumen Catheters due to a molding abnormality in the packaging component supplied by a vendor.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a packaging defect (molding abnormality) rather than a direct contamination or functional failure of the catheter itself, and no illnesses or injuries are reported in the source text.
Plain-English summary
Arrow International Inc. is recalling 6,121 units of Arrow Single-Lumen Catheters. The recall was initiated due to a notification of a component molding abnormality in the packaging material used for certain Arrow Select Kit (ASK) products.
The affected products are distributed in North Carolina, Ohio, Florida, and Maryland. The recall involves specific lot numbers, including 23F15L0662, 23F15J0260, and 23F15K0983, among others. The Arrow Single-Lumen Catheter is a medical device designed to permit venous access to the central circulation.
Consumers and healthcare facilities should check their inventory for the specific lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the supplier or the manufacturer as directed by Arrow International Inc.
The recalled product
- Product
- Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.
- 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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