FDA Device recall Z-0783-2020
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
- FDA Device
- Class II
- terminated
- Published 2020-01-15
On 2020-01-15 the FDA classified a Class II recall of Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 by Abbott Medical, citing fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0783-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-09 |
| Published | 2020-01-15 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Medical |
| Distribution | US |
Product
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Reason
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
Identifiers
| code_info | UDI: (01)15414734203903(17)220731(10)7133555, Batch: 7133555 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0783-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.