Device recall
Z-1427-2018: Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to…
FDA device recall · Class II · Halyard Health, Inc
Key facts
| Recall number (Z-number) | Z-1427-2018 |
|---|---|
| Recall event | 79531 |
| Product | Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); b. HALYARD* 12 FR TRACH CARE DSE ENDO; c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE); d. HALYARD*… |
| Product code | BSY |
| Recalling firm | Halyard Health, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 18, 2022 |
| FEI number | 3011270181 |
At a glance
- None 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