Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic device for endoscopic gastrointestinal use Component: No
Wilson-Cook Medical Inc.
The hazard
Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU). FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Version: N/A Product Description: Hemostatic device for endoscopic gastrointestinal use Component: No
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Lot Code: RPN: IHEMO-7Model HEMO-10Model HEMO-7-EUModel HEMO-10-EU Order Number: G56572Model G21049Model G24663Model 00827002210493Model 00827002246638UPC 00827002565722UPC 00827002210493UPC 00827002246638UPC 00827002213463Would you have heard about this one?
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