Apollo Endosurgery Inc recalls Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with p…

Recall date

November 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2743-2018

FDA classification

Class II

Brand / firm

Apollo Endosurgery Inc

Sold / distributed

Worldwide Distribution - FL, IL, LA, MI, MO, NC, NY, TN, TX, VA and WV and the countries of France, Italy, Spain, and United Kingdom

Why it was recalled

Component of the Lap-Band system was missing from the package

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The 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.