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Terminated

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.

FDA Recall Z-2732-2014 · Posted 2014-09-30

Recalling FirmApollo Endosurgery Inc
Recall StatusTerminated
Product CodeLTI
Date Initiated2014-08-15
Date Terminated2016-02-01
Product Quantity10

Reason for Recall

Product was distributed past its expiration date.

Firm Action

Firm called its consignees and advised them to either return or destroy the devices which had not already been implanted.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

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

Official Source

View FDA Recall →

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

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