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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2732-2014 | Class II | Terminated | Voluntary: Firm initiated |
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