Device recall
Z-0993-2011: Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279…
FDA device recall · Class I · Arstasis, Inc
Key facts
| Recall number (Z-number) | Z-0993-2011 |
|---|---|
| Recall event | 57507 |
| Product | Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the following components: (1) Device Sheath/Anchor, (2) Shaft and (3) Handle with control features. Product is manufactured and distributed by Arstasis Inc., San Carlos, CA The Arstasis One… |
| Product code | DYB |
| Recalling firm | Arstasis, Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 16, 2011 |
| 510(k) numbers | K091006, K100615, K102728 |
| FEI number | 3008493244 |
At a glance
- 1–9 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