Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and vaginal tissues
FDA device recall Z-0626-2009 · posted 2009-01-23 · Terminated
Recall details
- Recalling firm
- INGfertility, LLC
- Reason for recall
- Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).
- Action taken
- Firm telephoned all wholesale, clinic, and retail customers on 9/22/08 requesting that product be returned.
- Root cause
- Pending
- Status
- Terminated
- Product code
- NUC
- Quantity affected
- Unknown***
- Distribution
- Worldwide Distribution including USA and country of Ireland.
- Date initiated
- 2008-09-22
- Date posted
- 2009-01-23
- Date terminated
- 2012-05-02
- Location
- Valleyford, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRE' VAGINAL LUBRICANT (K051436) | Ingfertlity, LLC | 2006-10-13 |