Z-2541-2019 Class II Terminated
FDA device recall Z-2541-2019 was initiated by Wilson-Cook Medical Inc. on July 24, 2019 and is designated Class II. Reason for recall: Potential for Hemospray device to be unable to spray powder due to misassembly of devices. The recall status is terminated (terminated June 15, 2020). Affected quantity: 160 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2019
- Initiation Date
- July 24, 2019
- Termination Date
- June 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160 units
Product Description
Hemospray Endoscopic Hemostat
Reason for Recall
Potential for Hemospray device to be unable to spray powder due to misassembly of devices.
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.
Code Information
Model Numbers: HEMO-10, HEMO-10-EU, HEMO-7-EU; Lot Codes: W4179646, W4180858, W4180861, W4181073, W4180860, W4181071, W4189223, W4189224