Hemospray Endoscopic Hemostat

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

Code information: Model Numbers: HEMO-10, HEMO-10-EU, HEMO-7-EU; Lot Codes: W4179646, W4180858, W4180861, W4181073, W4180860, W4181071, W4189223, W4189224

Distribution pattern: 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.