Device recall
Z-0647-05: Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt, ***1000 ml…
FDA device recall · Class III · Teleflex Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0647-05 |
|---|---|
| Recall event | 31009 |
| Product | Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt, ***1000 ml Lot***Sterile EO***Manufactured and Distributed by***Rusch Inc. 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 1 |
| Product code | KNX |
| Recalling firm | Teleflex Medical, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 31, 2009 |
| 510(k) numbers | K871387 |
| FEI number | 2429473 |
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