LAPBAND Adjustable Gastric Band System

  • Model / Serial
    All Lot Numbers for the listed Product Codes are affected by this recall.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, AND WY
  • Product Description
    LAP-BAND Adjustable Gastric Band System; Product codes: || B-2105 (ACCSS PRT II KIT (0-10CC) US), || B-2106 (ACCESS PRT II KIT (0-14CC) US), || B-2210 (LP-BND SYS, 9.75, STER, US), || B-2215 (LAP-BAND 9.75 W/ACC PRT II US), || B-2220 (LP-BND SYS, 10.0, STER, US), || B-2225 (LAP-BND 10.0,ACCESS PORT II,US), || B-2255 (LAP-BAND VG W/ACS PORT II (US), || B-2260 (LP-BND AP STANDARD SYS, W ACC PRT II), || B-2265 (LP-BND AP LG SYS, W/ACC PRT II); || The Lap-Band System is a long-term implantable device intended to induce weight loss in morbidly obese patients by limiting food consumption restrictive and satiating, rather than malabsorptive). The device is surgically implanted, using either a laparoscopic or open procedure, to create a restricted opening (stoma) and a small gastric pouch to limit food consumption and induce early satiety. The main components of the device are the silicone elastomer band, access port. and kink-resistant tubing used to connect the other two components. The inner surface of the silicone band, which is placed around the stomach, is inflatable and connected by the tubing to the access port (a remote injection site. The access port is implanted on, or attached to, the rectus muscle to permit non-surgical, percutaneous adjustments to the band and thus, the stoma diameter, using sterile saline.
  • Manufacturer
  • 1 Event