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U.S. Department of Health and Human Services

Class 2 Device Recall Hemospray Endoscopic Hemostat

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 Class 2 Device Recall Hemospray Endoscopic Hemostatsee related information
Date Initiated by FirmJuly 24, 2019
Create DateSeptember 13, 2019
Recall Status1 Terminated 3 on June 15, 2020
Recall NumberZ-2541-2019
Recall Event ID 83395
Product Classification Hemostatic device for endoscopic gastrointestinal use - Product Code QAU
ProductHemospray Endoscopic Hemostat
Code Information Model Numbers: HEMO-10, HEMO-10-EU, HEMO-7-EU; Lot Codes: W4179646, W4180858, W4180861, W4181073, W4180860, W4181071, W4189223, W4189224
FEI Number 1037905
Recalling Firm/
Manufacturer		 Wilson-Cook Medical Inc.
4900 Bethania Station Rd
Winston Salem NC 27105-1203
For Additional Information Contact
800-457-4500
Manufacturer Reason
for Recall		Potential for Hemospray device to be unable to spray powder due to misassembly of devices.
FDA Determined
Cause 2		Under Investigation by firm
ActionCook 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 in Commerce160 units
DistributionNationwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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