Device recall
Z-0984-2017: Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ…
FDA device recall · Class II · MEDLINE IND
Key facts
| Recall number (Z-number) | Z-0984-2017 |
|---|---|
| Recall event | 75948 |
| Product | Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package. |
| Product code | KMJ |
| Recalling firm | MEDLINE IND |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 27, 2019 |
| 510(k) numbers | K041060 |
| FEI number | 1417592 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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