Reported Nov 19, 2014 · Terminated
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are…
American Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Medical Systems, Inc. · 10700 Bren Rd W · Minnetonka, MN · 55343-9679
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Number
184 of 184 codes
861912018861914016862631001862639018863952005863960024863962007865584018865585013865593007865869024865882006867705012868952010868961016868962022868964021869672008869673021869683007870935011870935017870936016870936023870937001870938022870940022871927006871927014871930002873243013873243015873247017873253025873944005873945017873946003873949005873950009873951024873952024875055017875060017875060024876016019876025002877253005877259010878159022878160012878162016878164009878165016878168017878168021878975023880215004880217014881145009881146023
- Lot Number
- Amount recalled
- 184 (110 US, 74 OUS)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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