Device recall
Z-1427-2012: Hudson RCI, BiteGard Oral Bite Block, Single Patient Use, Rx Only, Teleflex…
FDA device recall · Class II · Teleflex Medical
Key facts
| Recall number (Z-number) | Z-1427-2012 |
|---|---|
| Recall event | 61538 |
| Product | Hudson RCI, BiteGard Oral Bite Block, Single Patient Use, Rx Only, Teleflex Medical, Research Triangle Park, NC. The Teleflex Medical BiteGard Molar Bite Black is a disposable single patient use device that fits between the patients molars to prevent the patient from closing their mouth entirely and… |
| Product code | KOG |
| Recalling firm | Teleflex Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 20, 2014 |
| FEI number | 3005747797 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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