Reported Aug 22, 2018 · Terminated
Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with…
Apollo Endosurgery 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: Apollo Endosurgery Inc · 1120 S Capital Of Texas Hwy Ste 1 · West Lake Hills, TX · 78746-6464
Is this the product you have?
- Apollo Lap-Band AP System
- Small with RapidPort EZ Product UsageThe Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the bands together, an access port and silicone tubing that connects the band to the access port. The band is placed laparoscopically around the stomach, creating a small pouch or stoma, thereby limiting food consumption. The band can be inflated or deflated with saline, through the access port, depending on patient needs and progress. The Lap-Band access port is a low-profile cylindrical port attached to kink-resistant tubing . The port is implanted subcutaneously or in the rectus muscle and can be penetrated in its silicone septum by a non-coring needle to inject or remove saline into or from the band. The kink-resistant tubing connects the access port to the band
- Lot codes and dates
- Item Lot # Serial #
198 of 198 codes
C-2306AF00921S0034428C-2306AF00921S0034429C-2306AF00921S0034430C-2306AF00921S0034431C-2306AF00921S0034433C-2306AF00921S0034435C-2306AF00921S0034437C-2306AF00921S0034439C-2306AF00921S0034441C-2306AF00921S0034443C-2306AF00921S0034445C-2306AF00921S0034447C-2306AF00921S0034449C-2306AF00921S0034450C-2306AF00921S0034451C-2306AF00921S0034453C-2306AF00921S0034455C-2306AF00921S0034457C-2306AF00921S0034440C-2306AF00921S0034433
- Item Lot # Serial #
- Amount recalled
- 54
Where it was sold
Why it was recalled
Component of the Lap-Band system was missing from the package
This product could cause temporary or reversible health problems — stop using it.
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