FDA recall Z-2541-2019

Product

Hemospray Endoscopic Hemostat

Reason for recall

Potential for Hemospray device to be unable to spray powder due to misassembly of devices.

Distribution

Nationwide distribution to CA, CO, CT, FL, IL, IN, KY, LA, MN, MO, NC, NJ, NY, OH, PA, RI, SD, TX, VA, WA. International distribution to Canada, Austria, Belgium, Cyprus, Denmark, France, Germany, Greece, Italy, Portugal, Spain, and United Kingdom.

Key facts

Status

Terminated

Initiation date

2019-07-24

Report date

2019-09-25

Termination date

2020-06-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Winston Salem, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2541-2019