Recall Z-0783-2020 ยท DYB Introducer, Catheter
Abbott Medical
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
| Date | Dec 9, 2019 |
| Status | Terminated |
| Reason | Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices. |
| Root cause | Packaging |
| Action | Beginning on 12/09/2019, consignees were notified in person by an Abbott field representative. The firm is seeking return of the affected units. For questions about this issue or for replenishment contact your local Abbott Representative or Abbott Support at 1-855-478-5833 (option 1). |
| Quantity | 814 devices |
| Distribution | Worldwide Distributed - US Nationwide in sates of: FL, PA, NY, TX, MI CA, IL, NE, AL, NV, including PR and the countries of: Malaysia, Korea, Paraguay |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954317 | DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS Daig Corp., Nov 28, 1995 |