Device recall
Z-2013-2011: Lubricating Jelly packaged as follows: (1) DeRoyal(R) Water Soluble Lubricant…
FDA device recall · Class II · DeRoyal Processing Center
Key facts
| Recall number (Z-number) | Z-2013-2011 |
|---|---|
| Recall event | 58148 |
| Product | Lubricating Jelly packaged as follows: (1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF 31-702, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA; (2) DeRoyal(R) Water Soluble Lubricant, 1 / Pack, Size: 2 oz Rx Only, REF 31-704, STERILE EO, Distributor… |
| Product code | KMJ |
| Recalling firm | DeRoyal Processing Center |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 5, 2014 |
| 510(k) numbers | K871169 |
| FEI number | 1000208624 |
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