Device recall
Z-0072-2023: Iso-Gard Filter S, REF: a) 19211, OUS only; b) 19212; Microbial medical gas…
FDA device recall · Class I · TELEFLEX LLC
Key facts
| Recall number (Z-number) | Z-0072-2023 |
|---|---|
| Recall event | 90816 |
| Product | Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment. |
| Product code | CAH |
| Recalling firm | TELEFLEX LLC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K965016 |
| 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