Z-2732-2014 Class II Terminated
FDA device recall Z-2732-2014 was initiated by Apollo Endosurgery Inc on August 15, 2014 and is designated Class II. Reason for recall: Product was distributed past its expiration date. The recall status is terminated (terminated February 1, 2016). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- October 8, 2014
- Initiation Date
- August 15, 2014
- Termination Date
- February 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
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.
Distribution Pattern
Distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon.
Code Information
Lap-Band System AP Standard Catalog Number B-2240; Serial Numbers: 17760203, 17704664, 17704665, 17760205, 17760179, 17704672, 17704667, 17704659, 17760194, 17704653