Device recall
Z-1340-2015: FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO…
FDA device recall · Class II · Microtek Medical Inc
Key facts
| Recall number (Z-number) | Z-1340-2015 |
|---|---|
| Recall event | 70721 |
| Product | FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and… |
| Product code | FYA |
| Recalling firm | Microtek Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 21, 2017 |
| 510(k) numbers | K001082 |
| FEI number | 1043582 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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