FDA Device Recall Z-0783-2020: Abbott Medical

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0783-2020.

Recall Res Number

Z-0783-2020

Recalling Firm / Manufacturer

Abbott Medical

FEI Number

3005334138

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2019-12-09

Date Posted

N/A

Date Terminated

2020-12-14

Product Code

DYB

Event Number

84454

Product Quantity

814 devices

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.

Action Details 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).

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

Code Information / Serial Numbers UDI: (01)15414734203903(17)220731(10)7133555, Batch: 7133555

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Medical Device Recall: Z-0783-2020

Recall Parameters & Description

Related Establishments / Registrations

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