Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
FDA Recall Z-0783-2020 · Posted None
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Recalling FirmAbbott Medical
Recall StatusTerminated
Product CodeDYB
Date Initiated2019-12-09
Date Terminated2020-12-14
Product Quantity814 devices
Reason for Recall
Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
Firm Action
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).
Root Cause
Packaging
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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