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Recall Observatory FDA recall evidence

Device product

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.

Z-2732-2014

August 15, 2014

Class II

Product summary

Firm
Apollo Endosurgery Inc
Event
Event 69132
Status
Terminated
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-2732-2014

Official wording

Reason: Product was distributed past its expiration date.

Code information: Lap-Band System AP Standard Catalog Number B-2240; Serial Numbers: 17760203, 17704664, 17704665, 17760205, 17760179, 17704672, 17704667, 17704659, 17760194, 17704653

Distribution pattern: Distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product was distributed past its expiration date.