Recall Z-2103-2015— Allergan Inc
Class II · Terminated
Class II FDA medical device recall by Allergan Inc, initiated 2015-06-18, terminated 2015-12-16. It names one FDA 510(k) clearance: K862203. 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.. Reason: Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life..
- Recalling firm
- Allergan Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-18
- Terminated
- 2015-12-16
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.
Data sourced from openFDA. This site is unofficial and independent of the FDA.