Z-2541-2019Class II

Hemospray Endoscopic Hemostat

Name: Z-2541-2019 Hemospray Endoscopic Hemostat
Creator: Wilson-Cook Medical Inc.
Published: 2019-07-24
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2019-07-24 / Terminated

FDA source

Wilson-Cook Medical Inc. began a recall of Hemospray Endoscopic Hemostat on 2019-07-24. FDA classified it as Class II and gives the reason as "Potential for Hemospray device to be unable to spray powder due to misassembly of devices". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2541-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-24
Posted: 2019-09-13
Terminated: 2020-06-15
Recalling firm: Wilson-Cook Medical Inc.
Product: Hemospray Endoscopic Hemostat
Product code: QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Reason for recall: Potential for Hemospray device to be unable to spray powder due to misassembly of devices.
FDA 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 [email protected]. 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 [email protected], 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 in commerce: 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.
Product codes and lots: Model Numbers: HEMO-10, HEMO-10-EU, HEMO-7-EU; Lot Codes: W4179646, W4180858, W4180861, W4181073, W4180860, W4181071, W4189223, W4189224

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2541-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2541-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-25	2019-09-13

Product code QAU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)