medical Class II Updated 2018-08-22

Apollo Endosurgery Inc recalls Apollo Lap-Band AP System Small with RapidPort EZ Produc

Recalled Product

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.

Hazard / Issue

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

Issued by

FDA

Affected States: FL, IL, LA, MI, MO, NC, NY, TN, TX, VA, WV

Lot/Code Info: Item Lot # Serial # C-2306 AF00921 S0034428 C-2306 AF00921 S0034429 C-2306 AF00921 S0034430 C-2306 AF00921 S0034431 C-2306 AF00921 S0034433 C-2306 AF00921 S0034435 C-2306 AF00921 S0034437 C-2306 AF00921 S0034439 C-2306 AF00921 S0034441 C-2306 AF00921 S0034443 C-2306 AF00921 S0034445 C-2306 AF00921 S0034447 C-2306 AF00921 S0034449 C-2306 AF00921 S0034450 C-2306 AF00921 S0034451 C-2306 AF00921 S0034453 C-2306 AF00921 S0034455 C-2306 AF00921 S0034457 C-2306 AF00921 S0034440 C-2306 AF00921 S0034433 C-2306 AF00921 S0034450 C-2306 AF00921 S0034434 C-2306 AF00921 S0034436 C-2306 AF00921 S0034438 C-2306 AF00921 S0034444 C-2306 AF00921 S0034446 C-2306 AF00921 S0034448 C-2306 AF00921 S0034452 C-2306 AF00921 S0034454 C-2306 AF00921 S0034456 C-2306 AF00921 S0034442 C-2306 AF00921 S0034432 C-20360 AF00929 S0034459 C-20360 AF00929 S0034460 C-20360 AF00929 S0034461 C-20360 AF00929 S0034463 C-20360 AF00929 S0034464 C-20360 AF00929 S0034466 C-20360 AF00929 S0034467 C-20360 AF00929 S0034468 C-20360 AF00929 S0034469 C-20360 AF00929 S0034470 C-20360 AF00929 S0034472 C-20360 AF00929 S0034473 C-20360 AF00929 S0034460 C-20360 AF00929 S0034465 C-20360 AF00929 S0034480 C-20360 AF00929 S0034486 C-20360 AF00929 S0034467 C-20360 AF00929 S0034469 C-20360 AF00929 S0034473 C-20360 AF00929 S0034458 C-20360 AF00929 S0034462 C-20360 AF00929 S0034471 C-20360 AF00929 S0034474 C-20360 AF00929 S0034475 C-20360 AF00929 S0034476 C-20360 AF00929 S0034477 C-20360 AF00929 S0034478 C-20360 AF00929 S0034479 C-20360 AF00929 S0034481 C-20360 AF00929 S0034482 C-20360 AF00929 S0034483 C-20360 AF00929 S0034484 C-20360 AF00929 S0034485 C-20360 AF00929 S0034487

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