Health product recall

Fast-Cath Hemostasis Introducer (2019-12-09)

Starting date:
December 9, 2019
Posting date:
January 10, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72071



Last updated: 2020-01-10

Affected PRoducts

Fast-Cath Hemostasis Introducer

Reason

Abbott is voluntarily recalling three lots of Abbott Fast-Cath Hemostasis Introducer (model 406143, lot numbers 6917183, 6950628, and 7099144). As a result of a manufacturing error, these three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices.

Affected products

Fast-Cath Hemostasis Introducer

Lot or serial number
  • 6917183
  • 6950628
  • 7099144
Model or catalog number

406143

Companies
Manufacturer

St. Jude Medical

5050 Nathan Lane North

Plymouth

55442

Minnesota

UNITED STATES