[Recalled] Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until t
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed. |
|---|---|
| Brand / manufacturer | Allergan Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2103-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 18 June 2015 |
| EAN / barcode | 11250691 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Allergan Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.