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.
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 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.
See all 20 products in this recall →Related recalls
Same manufacturer · Arrow International Inc
See all →- HighArrow Arterial Kits Recalled Due to Open Packaging Seals
FDA (Devices) · 2024-10-02
- SevereIntra-Aortic Balloon Catheter Kit Recalled for Inflation and Structural Defects
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
FDA (Devices) · 2024-06-12
- SevereArrow Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereARROW QuickFlash Radial Artery Catheters Recalled for Defective Component
FDA (Devices) · 2024-03-27
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateArrow TheraCath Epidural Catheter Recalled for Incorrect Expiration Date
FDA (Devices) · 2020-08-19
- LowArrow Epidural Needle Component Recalled for Missing Shelf Life Labeling
FDA (Devices) · 2015-02-18
- SevereArrow International Recalls Epidural Catheterization Kits Due to Syringe Failures
FDA (Devices) · 2020-02-19
- SevereArrow International Recalls Epidural Catheterization Kits Due to Syringe Failure Risk
FDA (Devices) · 2020-02-19
- ModerateArrow PICC Catheters Recalled for Incorrect Expiration Date Labeling
FDA (Devices) · 2019-06-26
- ModerateArrow Single Shot Epidural Anesthesia Kit Recalled for Incorrect Expiration Date
FDA (Devices) · 2020-08-19