Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcut
FDA device recall Z-2103-2015 · posted 2015-07-18 · Terminated
Recall details
- Recalling firm
- Allergan Inc
- 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.
- Action taken
- A recall letter will be sent on 6/18/15 to all customers who received the NATRELLE 133 and CUI series tissue expanders. The letter provides the problem identified and the action to be taken. Customers are instructed to contact GENCO Pharmaceutical Services if the recall actions on the recall letter are unclear. For product returns, customers are instructed to contact GENCO at (877) 319-8966, 7am to 5pm CST. Customers with credit/reimbursements are instructed to contact Allergan at (800) 811-4148, 7am to 5pm PST. Customers with medical inquiries are instructed to contact (800) 433-8871, option 2, 8am-5pm, PST. Customers with adverse events/product complaints are instructed to call (800) 624-4261, option 3, 8am-5pm CST.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- LCJ
- Quantity affected
- 167 units total (114 units in US)
- Distribution
- US in the state of Canada
- Date initiated
- 2015-06-18
- Date posted
- 2015-07-18
- Date terminated
- 2015-12-16
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER (K862203) | Mcghan Medical Corp. | 1986-07-23 |