Z-0789-2020Class II

Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 -

Name: Z-0789-2020 Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 -
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 Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the... on 2019-12-09. FDA classified it as Class II and gives the reason as "Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F 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-0789-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-09
Posted: 2020-01-08
Terminated: 2020-12-11
Recalling firm: Abbott Medical
Product: Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Product code: DYB Introducer, Catheter
Reason for recall: Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.
Root cause tag: packaging
FDA root cause: Packaging
Action: Beginning on December 9, 2019, US consignees will be notified in person by an Abbott field representative. OUS consignees will be notified by mail. The firm is seeking return of the devices.
Quantity in commerce: 380 devices
Distribution: Worldwide distribution - US Nationwide distribution in the states of MA, VA, NH, FL, CT, UT, OH, WI, NY, IA, MI, MS, PA, and countries of Canada, Czech Republic
Product codes and lots: Batch 6917183; UDI (01)15414734014219(17)220228(10)6917183 Batch 6950628; UDI (01)15414734014219(17)220331(10)6950628 Batch 7099144; UDI (01)15414734014219(17)220630(10)7099144

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0789-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0789-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-15	2020-01-08

Product code DYB

K914090Class IIDaig Fast Cath(tm) Introducer, ModificationDaig Corp. / cleared 1991-10-28

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)