Arrow TheraCath Epidural Catheter Recalled for Incorrect Expiration Date
Arrow International Inc. is recalling TheraCath Epidural Catheters because the lidstock displays an incorrect expiration date, potentially leading to the use of expired devices.
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 labeling error (incorrect expiration date) with a theoretical risk of infection rather than reported injuries or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Arrow International Inc. is recalling the Arrow TheraCath Epidural Catheter, a medical device used to access the epidural space. The recall is due to a labeling error where the lidstock states the incorrect expiration date for the product.
The use of an expired device could potentially lead to an increased risk of infection or other complications. The sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.
The affected product is identified by Product Code EC-05000 and Lot # 13F18C0518. The product had worldwide distribution. Consumers and healthcare providers should check their inventory for this specific lot and product code and stop using the affected devices.
The recalled product
- Product
- Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.
- Manufacturer
- Arrow International Inc
- Hazard
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)
- Product Code: EC-05000 Lot #: 13F18C0518
Distribution
Distribution scope not specified by the agency.
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
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 Ultra 8 Intra-Aortic Balloon Catheter Kit Recalled for Inflation Defect
FDA (Devices) · 2024-06-12
- SevereArrow UltraFlex Intra-Aortic Balloon Catheter Kit Recalled for Device Malfunction
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 →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02