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Terminated

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.

FDA Recall Z-2743-2018 · Posted None

Recalling FirmApollo Endosurgery Inc
Recall StatusTerminated
Product CodeLTI
Date Initiated2017-11-22
Date Terminated2020-10-06
Product Quantity54

Reason for Recall

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

Firm Action

Consignees were initially contacted via telephone and later via letter. The firms letter requested the hospital risk manager dispose of the defective product.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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