Recall Z-0626-2009 ยท NUC Lubricant, Personal
INGfertility, LLC
Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and vaginal tissues to facilitate entry of diagnostic or therapeutic devices. Pre' Lubricant is acceptable for use to facilitate insertion of diagnostic or therapeutic devices during fertility interventions such as: embryo transfer, transvaginal collection of oocytes, intrauterine insemination and
| Date | Jan 23, 2009 (initiated Sep 22, 2008) |
| Status | Terminated |
| Reason | Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci). |
| Root cause | Pending |
| Action | Firm telephoned all wholesale, clinic, and retail customers on 9/22/08 requesting that product be returned. |
| Quantity | Unknown*** |
| Distribution | Worldwide Distribution including USA and country of Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051436 | PRE' VAGINAL LUBRICANT Ingfertlity, LLC, Oct 13, 2006 |