FDA recall Z-0624-2018

Product

JS Series SterilContainer S2 System

Reason for recall

The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall.

Distribution

Nationally

Key facts

Status

Terminated

Initiation date

2017-09-08

Report date

2018-02-21

Termination date

2019-04-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0624-2018