Recall Z-2541-2019 ยท QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Wilson-Cook Medical Inc.
Hemospray Endoscopic Hemostat
| Date | Jul 24, 2019 |
| Status | Terminated |
| Reason | Potential for Hemospray device to be unable to spray powder due to misassembly of devices. |
| Root cause | Under Investigation by firm |
| Action | Cook Medical notified customers starting on about 07/24/2019 via "URGENT: MEDICAL DEVICE RECALL" letter. Customers were informed that complaints have been received by Cook Medical that the Hemospray device is potentially unable to spray powder due to misassembly of the device. The potential risk involved includes delayed hemostasis, the need for additionaly hemostasis, and/or the patient may need to be transferred to surgery. If Hemostasis cannot be achieved in a timely manner in emergent cases, this may result in death. Instructions to customers include to immediately review the labels of |
| Quantity | 160 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.