notyard
04-14-2009, 12:22 PM
FDA class II recall:
PRODUCT
Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and vag inal 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, transvag inal 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. Recall # Z-0626-2009
CODE
Lot number: 5213
RECALLING FIRM/MANUFACTURER
Recalling Firm: INGfertility, LLC, Valleyford, WA, by telephone on September 22, 2008.
Manufacturer: Unicep Packaging, Inc., Sandpoint, ID. Firm initiated recall is ongoing.
REASON
Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and Ireland
PRODUCT
Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and vag inal 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, transvag inal 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. Recall # Z-0626-2009
CODE
Lot number: 5213
RECALLING FIRM/MANUFACTURER
Recalling Firm: INGfertility, LLC, Valleyford, WA, by telephone on September 22, 2008.
Manufacturer: Unicep Packaging, Inc., Sandpoint, ID. Firm initiated recall is ongoing.
REASON
Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and Ireland