Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2732-2014Class II

LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was...

Apollo Endosurgery, Inc. / initiated 2014-08-15 / Terminated / root cause: software

Apollo Endosurgery Inc began a recall of 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... on . FDA classified it as Class II and gives the reason as "Product was distributed past its expiration date". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-2732-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Apollo Endosurgery, Inc.
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.
Product code
LTI Implant, Intragastric For Morbid Obesity
Reason for recall
Product was distributed past its expiration date.
Root cause tag
software
FDA root cause
Software Manufacturing/Software Deployment
Action
Firm called its consignees and advised them to either return or destroy the devices which had not already been implanted.
Quantity in commerce
10
Distribution
Distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon.
Product codes and lots
Lap-Band System AP Standard Catalog Number B-2240; Serial Numbers: 17760203, 17704664, 17704665, 17760205, 17760179, 17704672, 17704667, 17704659, 17760194, 17704653

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2732-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2732-2014Class IITerminatedVoluntary: Firm initiated