Z-0626-2009

Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and...

Name: Z-0626-2009 Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and...
Creator: INGfertility, LLC
Published: 2008-09-22
License: https://open.fda.gov/license/

Ingfertility, LLC / initiated 2008-09-22 / Terminated

FDA source

INGfertility, LLC began a recall of Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and vaginal tissues to facilitate entry of diagnostic or... on 2008-09-22. The reason FDA records is "Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0626-2009
Status: Terminated
Initiated: 2008-09-22
Posted: 2009-01-23
Terminated: 2012-05-02
Recalling firm: Ingfertility, LLC
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.
Product code: NUC Lubricant, Personal
Reason for recall: Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).
FDA root cause: Pending
Action: Firm telephoned all wholesale, clinic, and retail customers on 9/22/08 requesting that product be returned.
Quantity in commerce: Unknown***
Distribution: Worldwide Distribution including USA and country of Ireland.
Product codes and lots: Lot 5213.

Product code NUC

K051436Class IIPre' Vaginal LubricantIngfertlity, LLC / cleared 2006-10-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)