FDA recall Z-2536-2017

Product

Stamey Needle

Reason for recall

reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products

Distribution

The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.

Key facts

Status

Terminated

Initiation date

2017-04-25

Report date

2017-06-21

Termination date

2019-03-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2536-2017