Device recall
Z-1537-2012: HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is…
FDA device recall · Class II · Haemacure Corporation
Key facts
| Recall number (Z-number) | Z-1537-2012 |
|---|---|
| Recall event | 61636 |
| Product | HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch label***HAEMACURE***HemaSyst***tm***Contents: One ***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604*** CE 0297***LOT 111144***2014/10***40680b/20004-02***CAUTION: U.S. Federal… |
| Product code | KYZ |
| Recalling firm | Haemacure Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 14, 2012 |
| 510(k) numbers | K883338 |
| FEI number | 3001722649 |
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