Recall Z-0626-2009
INGfertility, LLC · initiated September 22, 2008
Product
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 post coital testing. In addition, product may be used as a personal lubricant to supplement the body's own natural lubricating fluids.
Codes / lots: Lot 5213.
Reason for recall
Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).
FDA-determined cause: Pending
Action taken
Firm telephoned all wholesale, clinic, and retail customers on 9/22/08 requesting that product be returned.
Details
- Recall number
- Z-0626-2009
- Initiated
- September 22, 2008
- Posted by FDA
- January 23, 2009
- Terminated
- May 2, 2012
- Product code
- NUC – Lubricant, Personal
- Quantity
- Unknown***
- Distribution
- Worldwide Distribution including USA and country of Ireland.
- Recalling firm
- INGfertility, LLC, Valleyford, WA