Device recall
Z-3172-2011: Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela…
FDA device recall · Class II · Medela Inc
Key facts
| Recall number (Z-number) | Z-3172-2011 |
|---|---|
| Recall event | 59453 |
| Product | Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare, McHenry, IL 60051; A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, transparent dressing, tubing clamp, barrier film wipe, adhesive tape, sterile saline… |
| Product code | MCY |
| Recalling firm | Medela Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 16, 2012 |
| 510(k) numbers | K080357 |
| FEI number | 1419937 |
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