FDA recall Z-1892-2018

Product

Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.

Reason for recall

Scalpels lot contains non-sterile products labeled as sterile.

Distribution

US Distribution to the states of : IA, IL, NE, NY and TX

Key facts

Status

Terminated

Initiation date

2017-11-06

Report date

2018-05-23

Termination date

2020-04-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Barrie, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1892-2018