Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-2803-2020 · Posted None

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeCAZ
Date Initiated2020-07-06
Date Terminated2021-11-05

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.

Firm Action

Arrow sent a customer notification letter dated July 6, 2020. This letter informed customers of the affected product, asked them to check and remove inventory, and complete the response form.

Root Cause

Incorrect or no expiration date

Distribution Pattern

World wide distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K801912ARROW POSITIVE PLACEMENT CON/EPIDURAL ANArrow Intl., Inc. · 1980-09-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑