Z-0783-2020Class II

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

Name: Z-0783-2020 Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Creator: Abbott Medical
Published: 2019-12-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-12-09 / Terminated / root cause: packaging

FDA source

Abbott Medical began a recall of Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 on 2019-12-09. FDA classified it as Class II and gives the reason as "Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0783-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-09
Posted: 2020-01-07
Terminated: 2020-12-14
Recalling firm: Abbott Medical
Product: Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Product code: DYB Introducer, Catheter
Reason for recall: Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices.
Root cause tag: packaging
FDA root cause: Packaging
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).
Quantity in commerce: 814 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
Product codes and lots: UDI: (01)15414734203903(17)220731(10)7133555, Batch: 7133555

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0783-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0783-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-15	2020-01-07

Product code DYB

K954317Class IIDiag Fast-Cath Duo & Trio Removable Hemostasis Adapters W/sideports & 3-Way StopcocksDaig Corp. / cleared 1995-11-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)