Recall Z-1904-2009 ยท NUC Lubricant, Personal
Memphis Fertility Laboratory Inc
ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN Intended Use: Personal Lubricant.
| Date | Aug 27, 2009 (initiated Jul 10, 2009) |
| Status | Terminated |
| Reason | Product was marketed without a 510(k). |
| Root cause | PMA |
| Action | The firm notified its sole consignee on 07/10/2009 by telephone and followed by an Urgent Medical Device Recall letter. The letter requested that they examine their inventory and quarantine all products subject to recall and immediately contact Dr. William Kutteh for return instructions. The enclosed response form should be completed and returned. Questions should be directed to Dr. Kutteh at 901-261-2401. |
| Quantity | 800 units |
| Distribution | Nationwide Distribution -- USA, including the state of MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.