Device recall
Z-2645-2026: Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN…
FDA device recall · Class II · Medela Inc
Key facts
| Recall number (Z-number) | Z-2645-2026 |
|---|---|
| Recall event | 99100 |
| Product | Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit Component: N/A |
| Product code | FPA |
| Recalling firm | Medela Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K895367 |
| FEI number | 1419937 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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