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