FDA-Device2014-10-08Class II
LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.
Apollo Endosurgery Inc
Hazard
Product was distributed past its expiration date.
Sold states
Distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon.
Affected count
10
Manufactured in
1120 S Capital Of Texas Hwy, Bldg. 1, Ste. 300, West Lake Hills, TX, United States
Products
LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2732-2014Don't want to check this manually?
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