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

Is my product affected?

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

• UPC 15414734203903

Check against the official notice below — it lists the full affected range.

What happened

Abbott Medical is recalling 814 Fast-Cath Trio Hemostasis Introducer devices (14F, 4.6 mm, REF 406303) because they contained 12F sized dilators and sheaths instead of the expected 14F devices. The affected devices have UDI (01)15414734203903(17)220731(10)7133555 and Batch 7133555. These devices were distributed worldwide, including throughout the United States in Florida, Pennsylvania, New York, Texas, Michigan, California, Illinois, Nebraska, Alabama, Nevada, and Puerto Rico, as well as in Malaysia, Korea, and Paraguay.

The recall notice does not specify a remedy or actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F 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 Quantity: 814 devices Lot/code info: UDI: (01)15414734203903(17)220731(10)7133555, Batch: 7133555

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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