Recall Z-0783-2020— Abbott Medical

Name: FDA recall Z-0783-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-09

Class II · Terminated

Class II FDA medical device recall by Abbott Medical, initiated 2019-12-09, terminated 2020-12-14. It names one FDA 510(k) clearance: K954317. 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..

Recalling firm: Abbott Medical
Classification: Class II
Status: Terminated
Initiated: 2019-12-09
Terminated: 2020-12-14
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K954317 — DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKSDaig Corp.·cleared 1995-11-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303

Reason for recall

Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.

Data sourced from openFDA. This site is unofficial and independent of the FDA.