FDA Medical Device Recalls (openFDA)
INGfertility, LLC: 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.
- Recall number
- Z-0626-2009
- 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.
- Status
- Terminated
- Initiated
- 2008-09-22
- Posted
- 2009-01-23
- Terminated
- 2012-05-02
- Reason
- Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).
- Root cause
- Pending
- Action
- Firm telephoned all wholesale, clinic, and retail customers on 9/22/08 requesting that product be returned.
- Quantity
- Unknown***
- Distribution
- Worldwide Distribution including USA and country of Ireland.
- Lot, serial or model codes
- Lot 5213.
- 510(k) numbers
- ["K051436"]
- PMA numbers
- not on file
- Product code
- NUC
- Firm FEI
- 3006029862
- Firm city
- Valleyford
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28