Device recall
Z-2006-2020: Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT…
FDA device recall · Class II · Ra Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2006-2020 |
|---|---|
| Recall event | 85344 |
| Product | Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT… |
| Product code | PDU |
| Recalling firm | Ra Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 31, 2023 |
| 510(k) numbers | K170349 |
| FEI number | 3004217728 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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