Device recall
Z-1442-05: Guidant Lead Tunneler Kit model 6927. Accessory Kit for use with the Endotak SQ…
FDA device recall · Class II · Guidant Corporation
Key facts
| Recall number (Z-number) | Z-1442-05 |
|---|---|
| Recall event | 32395 |
| Product | Guidant Lead Tunneler Kit model 6927. Accessory Kit for use with the Endotak SQ Lead Array. Contains one tunneler and four sheaths. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue, St. Paul, MN 55112-5798. |
| Product code | DYB |
| Recalling firm | Guidant Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 5, 2007 |
| PMA numbers | P910073, P910073/S3 |
| FEI number | 2124215 |
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