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.
FDA Recall Z-0626-2009 · Posted 2009-01-23
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Recalling FirmINGfertility, LLC
Recall StatusTerminated
Product CodeNUC
Date Initiated2008-09-22
Date Terminated2012-05-02
Product QuantityUnknown***
Reason for Recall
Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).
Firm Action
Firm telephoned all wholesale, clinic, and retail customers on 9/22/08 requesting that product be returned.
Root Cause
Pending
Distribution Pattern
Worldwide Distribution including USA and country of Ireland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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