AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number 861912018 861914016 862631001 862639018 863952005 863960024 863962007 865584018 865585013 865593007 865869024 865882006 867705012 868952010 868961016 868962022 868964021 869672008 869673021 869683007 870935011 870935017 870936016 870936023 870937001 870938022 870940022 871927006 871927014 871930002 873243013 873243015 873247017 873253025 873944005 873945017 873946003 873949005 873950009 873951024 873952024 875055017 875060017 875060024 876016019 876025002 877253005 877259010 878159022 878160012 878162016 878164009 878165016 878168017 878168021 878975023 880215004 880217014 881145009 881146023 881149014 881150018 881152025 882234015 882236002 882239002 882240012 882241016 882243015 882245014 883312010 883313020 883315019 883319013 883319014 883319015 884416007 884416024 884420017 884422015 884422018 884423025 885166007 885166024 885170004 885170022 886256007 886256021 886257022 886260022 886260024 886260025 886261024 886262010 886263002 886263017 886264010 886264024 886848011 886848012 886849016 886855001 886855019 886858004 886858011 886858014 887908021 887909002 887909003 887909008 887910017 887912005 887912006 887915009 887917021 888755008 888755012 888758013 888762005 888762015 889654010 889656003 889656005 889656006 889656023 889657013 889657014 890573015 890573017 890576003 890577015 890578013 890579011 890579016 890580017 890581001 890581002 890581003 890581004 890581005 890581006 890581007 890581018 890581024 890582011 890582012 890582013 891506011 891506012 891507012 891507014 891507021 891508002 891508019 891508020 891508021 891509005 891509006 891510011 891511001 891511002 891513002 891513003 891513024 891515003 891516015 892497013 892497014 892498002 892501001 892501002 892501003 892501004 892501012 892501016 892501017 892501018 892501019 892501020 892501021 892501022 892501023 892501024 892501025
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- American Medical Systems, Inc.
- Reason for Recall:
- AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS 700 Accessory Kits. Based on this, AMS is recalling AMS 700 Accessory Kits which contain these lots of needles. The supplier made the decision to issue this recall after an internal investigation that was requested by AMS. The investigation identified a potential nonconformity that may lead to a bent or broken Keith Needle when used with the Furlow tool.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700 cylinders in the corpus cavernosa.
Product Codes/Lot Numbers:
Lot Number 861912018 861914016 862631001 862639018 863952005 863960024 863962007 865584018 865585013 865593007 865869024 865882006 867705012 868952010 868961016 868962022 868964021 869672008 869673021 869683007 870935011 870935017 870936016 870936023 870937001 870938022 870940022 871927006 871927014 871930002 873243013 873243015 873247017 873253025 873944005 873945017 873946003 873949005 873950009 873951024 873952024 875055017 875060017 875060024 876016019 876025002 877253005 877259010 878159022 878160012 878162016 878164009 878165016 878168017 878168021 878975023 880215004 880217014 881145009 881146023 881149014 881150018 881152025 882234015 882236002 882239002 882240012 882241016 882243015 882245014 883312010 883313020 883315019 883319013 883319014 883319015 884416007 884416024 884420017 884422015 884422018 884423025 885166007 885166024 885170004 885170022 886256007 886256021 886257022 886260022 886260024 886260025 886261024 886262010 886263002 886263017 886264010 886264024 886848011 886848012 886849016 886855001 886855019 886858004 886858011 886858014 887908021 887909002 887909003 887909008 887910017 887912005 887912006 887915009 887917021 888755008 888755012 888758013 888762005 888762015 889654010 889656003 889656005 889656006 889656023 889657013 889657014 890573015 890573017 890576003 890577015 890578013 890579011 890579016 890580017 890581001 890581002 890581003 890581004 890581005 890581006 890581007 890581018 890581024 890582011 890582012 890582013 891506011 891506012 891507012 891507014 891507021 891508002 891508019 891508020 891508021 891509005 891509006 891510011 891511001 891511002 891513002 891513003 891513024 891515003 891516015 892497013 892497014 892498002 892501001 892501002 892501003 892501004 892501012 892501016 892501017 892501018 892501019 892501020 892501021 892501022 892501023 892501024 892501025
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0209-2015
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