Arrow TheraCath Epidural Catheters Recalled for Unsealed Packaging
Arrow International is recalling TheraCath Epidural Catheters because unsealed packaging may compromise sterility. The recall covers 416,055 units distributed in the US and 33 other countries.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterility may be compromised, posing a risk of harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arrow International Inc is recalling TheraCath(R) Epidural Catheters (Product Code: EC-05000) due to a potential sterility issue. The recall is caused by unsealed packaging, which may compromise the sterility of the product.
The recall affects 416,055 total products. Distribution was US Nationwide and included 33 other countries, including Australia, Canada, the United Kingdom, and Germany. Specific lot numbers are listed in the agency's structured data.
Consumers and healthcare providers should stop using the affected products and contact Arrow International Inc for instructions on return or replacement.
The recalled product
- Product
- TheraCath(R) Epidural Catheter; Product Code: EC-05000
- Manufacturer
- Arrow International Inc
- Affected units
- 416,055
Distribution
Part of a larger recall action
This product is one of 76 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 76 products in this recall →Related recalls
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Similar recalls
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- ModerateArrow TheraCath Epidural Catheter Recalled for Incorrect Expiration Date
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