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U.S. Department of Health and Human Services

Class 2 Device Recall PRE' VAGINAL LUBRICANT

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  Class 2 Device Recall PRE' VAGINAL LUBRICANT see related information
Date Initiated by Firm September 22, 2008
Date Posted January 23, 2009
Recall Status1 Terminated 3 on May 02, 2012
Recall Number Z-0626-2009
Recall Event ID 49591
510(K)Number K051436  
Product Classification Lubricant, patient, vaginal, latex compatible - Product Code NUC
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.
Code Information Lot 5213.
Recalling Firm/
Manufacturer		 INGfertility, LLC
17206 S Spangle Creek Rd
Valleyford WA 99036-9569
For Additional Information Contact
509-443-0149
Manufacturer Reason
for Recall		 Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NUC and Original Applicant = INGFERTLITY, LLC
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