Recall Z-2732-2014— Apollo Endosurgery Inc
Class II · Terminated
Class II FDA medical device recall by Apollo Endosurgery Inc, initiated 2014-08-15, terminated 2016-02-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Product was distributed past its expiration date..
- Recalling firm
- Apollo Endosurgery Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-15
- Terminated
- 2016-02-01
- Firm location
- West Lake Hills, TX, United States
Product description
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.
Reason for recall
Product was distributed past its expiration date.
Data sourced from openFDA. This site is unofficial and independent of the FDA.