Device recall
Z-0959-2021: PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle…
FDA device recall · Class II · Prytime Medical Devices, Inc.
Key facts
| Recall number (Z-number) | Z-0959-2021 |
|---|---|
| Recall event | 87099 |
| Product | PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA… |
| Product code | OFC |
| Recalling firm | Prytime Medical Devices, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2022 |
| FEI number | 3026788751 |
At a glance
- None 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