Recall Z-2103-2015 ยท LCJ Tissue Expander And Accessories
Allergan Inc
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.
| Date | Jul 18, 2015 (initiated Jun 18, 2015) |
| Status | Terminated |
| Reason | Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life. |
| Root cause | Incorrect or no expiration date |
| Action | 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 |
| Quantity | 167 units total (114 units in US) |
| Distribution | US in the state of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862203 | MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER Mcghan Medical Corp., Jul 23, 1986 |