Reported May 27, 2020 · Terminated
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair…
W L Gore & Associates, 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: W L Gore & Associates, Inc. · 1500 N 4th St · Flagstaff, AZ · 86004-5866
Is this the product you have?
- Conformable Thoracic Stent Graft, Rx only
- Sterile EO - Product UsageThis device is intended for endovascular repair of lesions of the descending thoracic aorta
- Lot codes and dates
- Part number of
- the device is TGM343420J Serial numbers
2122506521225066212250672122506821225069212250702122507121225072212250732122507421225075212250762122507721225078212250792122508021225081212250822122508321225084
- Amount recalled
- 15 stents
Why it was recalled
The incorrect label was placed on both the primary and secondary package.
This product could cause temporary or reversible health problems — stop using it.
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