TorFlex Transseptal Guiding Sheath (2019-10-08)

Starting date:

October 8, 2019

Posting date:

November 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-71599

Last updated: 2019-11-15

• Reason
• Affected products

Affected Products

TorFlex Transseptal Guiding Sheath

Reason

A recall is being undertaken due to the remote potential for the TorFlex Transseptal Guiding Sheath sterile packaging to be compromised during shipping/handling. The potential issue was identified through internal investigations and confirmed on 30-Sep-2019. To date, no related adverse event or patient injury has been reported. The action is being taken as a cautionary measure to avoid the remote possibility of patient infection due to compromised packaging sterility (see Appendix B).

Affected products