Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
- Company
- Wilson-Cook Medical Inc
- Recall Initiated
- May 22, 2023
- Posted
- June 21, 2023
- Recall Number
- Z-1979-2023
- Quantity
- 14,877 units
- Firm Location
- Winston Salem, NC
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.
Distribution
US Nationwide - Worldwide Distribution
Lot / Code Info
UDI/DI : a) 00827002210493, b) 00827002213463; All unexpired lot numbers
Root Cause
Under Investigation by firm
Action Taken
The 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.
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