Device recall
Z-3079-2017: MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film…
FDA device recall · Class II · Master & Frank (Pinghu) Co., Ltd.
Key facts
| Recall number (Z-number) | Z-3079-2017 |
|---|---|
| Recall event | 77633 |
| Product | MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns. |
| Product code | FYA |
| Recalling firm | Master & Frank (Pinghu) Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K964142 |
| FEI number | 3006973666 |
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