Recall record at a glance
| Official record | Z-2732-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Apollo Endosurgery Inc. |
| Report date | Oct 8, 2014 |
| Recall initiation date | Aug 15, 2014 |
| Quantity | 10 |
| Location | West Lake Hills, TX, United States |
Official 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.
Why the product was recalled
Product was distributed past its expiration date.
Distribution information
Distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Telephone.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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