# FDA recall Z-2803-2020

> **Arrow International Inc** · Class II · device recall initiated 2020-07-06.

## Product

Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.

## Reason for recall

The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility, biocompatibility, safety, or efficacy of the kits and their components are not assured beyond the correct expiration date.

## Distribution

World wide distribution

## Key facts

- **Recall number:** Z-2803-2020
- **Recalling firm:** Arrow International Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-06
- **Report date:** 2020-08-19
- **Termination date:** 2021-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Reading, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2803-2020

## Citation

> AI Analytics. FDA recall Z-2803-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2803-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*