Health product recall

Transseptal Needle Sets (2019-01-31)

Starting date:
January 31, 2019
Posting date:
February 15, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69040

Affected Products

Transseptal Needle Sets

Reason

These products are being recalled because Cook has identified that a specific lot of Transseptal Needles were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.

Affected products

Transseptal Needle Sets

Lot or serial number

8833687

Model or catalog number

TSNC-18-71.0

Companies
Manufacturer

Cook Inc.

750 Daniels Way

Bloomington

47404

Indiana

UNITED STATES