FDA-Device2020-08-19Class II

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

Arrow International Inc
Hazard

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.

Sold states
World wide distribution
Affected count
N/A
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.

Official notice

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

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