Device recall
Z-0626-2009: Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used…
FDA device recall · Class II · INGfertility, LLC
Key facts
| Recall number (Z-number) | Z-0626-2009 |
|---|---|
| Recall event | 49591 |
| 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… |
| Product code | NUC |
| Recalling firm | INGfertility, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 2012 |
| 510(k) numbers | K051436 |
| FEI number | 3006029862 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database