Device recall
Z-0497-2020: WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965…
FDA device recall · Class II · Teleflex Medical
Key facts
| Recall number (Z-number) | Z-0497-2020 |
|---|---|
| Recall event | 84032 |
| Product | WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips |
| Product code | FZP |
| Recalling firm | Teleflex Medical |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K021808 |
| FEI number | 3005747797 |
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