Arrow Epidural Catheterization Component Recalled for Incorrect Expiration Date
Arrow International Inc. is recalling 540 units of the Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000 because the product lidstock contains the incorrect expiration date.
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 specific defect is a labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Arrow International Inc. is recalling 540 units of the Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000. The recall was initiated because the product lidstock contains the incorrect expiration date for the product.
The affected units are identified by Lot Number 13F18D0313. The products were distributed nationwide and to foreign countries including AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA.
Healthcare providers and consumers should stop using the affected product and contact Arrow International Inc. for further instructions or a return.
The recalled product
- Product
- Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000
- Manufacturer
- Arrow International Inc
- Hazard
- Affected units
- 540
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 (1)
- Lot Number: 13F18D0313
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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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