FDA recall Z-2801-2020

Product

Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Needle Single Shot Epidural Kit 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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2801-2020