FDA Medical Device Recalls (openFDA)
Wilson-Cook Medical Inc.: Hemospray Endoscopic Hemostat
- Recall number
- Z-2541-2019
- Recalling firm
- Wilson-Cook Medical Inc.
- Product
- Hemospray Endoscopic Hemostat
- Status
- Terminated
- Initiated
- 2019-07-24
- Posted
- not on file
- Terminated
- 2020-06-15
- 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 impacted in inventory and quarantine any affected product that remains unused. All affected product on hand should be returned to Cook Medical and include the completed Acknowledgement and Receipt Form. The response form should be returned via fax (812.339.7316) or email FieldActionsNA@CookMedical.com. If the customer is a distributor, and the products have been further distributed, contact all customers and direct them to quarantine any affected product. For questions, please contact the Customer Relations Department at Cook Medical for more information or if you have questions. Please use FieldActionsNA@CookMedical.com, or call toll free 1-800-457-4500, press 4, then enter extension 15-2146, Monday through Friday, 8:00AM to 4:30PM, Eastern Time.
- 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.
- Lot, serial or model codes
- Model Numbers: HEMO-10, HEMO-10-EU, HEMO-7-EU; Lot Codes: W4179646, W4180858, W4180861, W4181073, W4180860, W4181071, W4189223, W4189224
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QAU
- Firm FEI
- 1037905
- Firm city
- Winston Salem
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28