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U.S. Department of Health and Human Services

Class 2 Device Recall Hemospray Endoscopic Hemostat HEMO7, HEMO7EU

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 Class 2 Device Recall Hemospray Endoscopic Hemostat HEMO7, HEMO7EUsee related information
Date Initiated by FirmMay 22, 2023
Date PostedJune 21, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1978-2023
Recall Event ID 92345
510(K)NumberK200972 
Product Classification Hemostatic device for endoscopic gastrointestinal use - Product Code QAU
ProductHemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
Code Information UDI/DI : a) 00827002565722, b) 00827002246638; All unexpired lot numbers
FEI Number 1037905
Recalling Firm/
Manufacturer		 Wilson-Cook Medical Inc.
4900 Bethania Station Rd
Winston Salem NC 27105-1203
For Additional Information ContactCook Medical Customer Relations
800-457-4500
Manufacturer Reason
for Recall		There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm notified their consignees by letter and email beginning on 05/22/2023. The notice explained the issue, risk, and requested the following: Complete and return the Acknowledgement Form, ensure the notification is shared with appropriate personnel, down to the user level or customers if devices were further distributed, report any adverse events.
Quantity in Commerce63,830 units
DistributionUS Nationwide - Worldwide Distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QAU
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