Abbott Medical: Medical Device Recall in 2020 - (Recall #: Z-0783-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 9, 2019

Date Posted: January 15, 2020

Recall Number: Z-0783-2020

Event ID: 84454

Reason for Recall:

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

Status: Terminated

Product Quantity: 814 devices

Code Information:

UDI: (01)15414734203903(17)220731(10)7133555, Batch: 7133555

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated