United StatesHEMOSPRAY Endoscopic Hemostat (models/catalog numbers HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU), a hemostatic device for endoscopic gastrointestinal use, is being recalled worldwide and applies to all lot numbers of Hemospray (UDIs and work order numbers are listed). The recall was initiated because of an issue with endoscope adherence and inability to spray powder; the firm will provide an updated Instruction for Use (IFU).
What's being recalled
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
Recalling firm: Wilson-Cook Medical Inc., Winston Salem, NC, United States.
How to identify it
Lot Code: RPN: IHEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Order Number: G56572, G21049, G24663, G21346 Affected Lot Numbers and MFG/EXP Dates: The information supplied in this letter applies to all lot numbers of Hemospray. UDI: 00827002565722; 00827002210493; 00827002246638; 00827002213463 HEMO-7 Work Order Numbers: W4744012 W4744013 W4744014 W4744015 W4744016 W4744017 W4744103 W4744104 W4744504 W4744506 W4744507 W4744508 W4744509 W4744510 W4744511 W4744575 W4744576 W4744828 W4744829 W4744830 W4744831 W4744832 W4744834 W4744905 W4744906 W4745140 W4745141 W4745142 W4745144 W4745145 W4745146 W4745147 W4745262 W4745263 W4745408 W4745409 W4745411 W4745412 W4745488 W4745489 W4746024 W4746025 W4746026 W4746027 W4746028 W4746029 W4746030 W4746494 W4746495 W4746496 W4746497 W4746498 W4746499 W4746500 W4746639 W4746640 W4746909 W4746910 W4746911 W4746912 W4746913 W4746915 W4747100 W4747374 W4747375 W4747377 W4747378 W4747379 W4747380 W4747381 W4747802 W4747803 W4747805 W4747806 W4747807 W4748859 W4748860 W4748865 W4748866 W4748930 W4748931 W4749220 W4749221 W4749222 W4749223 W4749224 W4749225 W4749226 W4749422 W4749423 W4749736 W4749737 W4749738 W4749739 W4749740 W4749741 W4749742 W4749971 W4749972 W4749995 W4750254 W4750255 W4750256 W4750257 W4750259 W4750260 W4750444 W4750445 W4750465 W4750614 W4750616 W4750617 W4750618 W4750619 W4750873 W4750874 W4750904 W4751075 W4751076 W4751077 W4751078 W4751079 W4751080 W4751249 W4751250 W4751337 W4751501 W4751502 W4751503 W4751504 W4751740 W4751741 W4751742 W4751779 W4751897 W4751898 W4751899 W4751900 W4751901 W4752132 W4752133 W4752342 W4752343 W4752347 W4752348 W4752518 W4752519 W4752996 W4752997 W4752998 W4752999 W4753000 W4753001 W4753002 W4753197 W4753453 W4753454 W4753456 W4753457 W4753458 W4753459 W4753651 W4753652 W4753677 W4753879 W4753880 W4753881 W4753882 W4753885 W4753886 W4754061 W4754062 W4754326 W4754329 W4754330 W4754331 W4754332 W4754333 W4754504 W4754505 W4754731 W4754732 W4754733 W4754734 W4754735 W4754739 W4754740…
The hazard
Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU).
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Argentina, Australia, Austria, Bahrain, Belgium, Brunei Darussalam, Brazil, Canada, Canary Island, Chile, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Greece, Guatemala, Guadeloupe, Guernsey, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jersey, Japan, Kuwait, Latvia, Lithuania, Luxembourg, Malta, Martinique, Mexico, Myanmar, Macau, Monaco, Malaysia, New Caledonia, Netherlands, Norway, New Zealand, Oman, Panama, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovenia, El Salvador, South Africa, Spain, Sweden, Switzerland, Thailand, Taiwan, United Arab Emirates, United Kingdom, and Vietnam.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)