Health product recall

ARROW-TREROTOLA OVER-THE-WIRE PTD KIT (2021-09-22)

Starting date:
September 22, 2021
Posting date:
October 1, 2021
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-76567



Last updated:
2021-10-01

Affected Products

ARROW-TREROTOLA OVER-THE-WIRE PTD KIT

Reason

Teleflex is initiating a voluntary field safety corrective action due to reports received indicating that the ptd's inner lumen (orange) detached from the device's basket.

Affected products

ARROW-TREROTOLA OVER-THE-WIRE PTD KIT

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • PT-12709-WC
  • PT-65709-HFWC
  • PT-65709-W
  • PT-65709-WC
Companies
Manufacturer

ARROW INTERNATIONAL LLC SUBSIDIARY OF TELEFLEX INCORPORATED

3015 CARRINGTON MILL BLVD.

MORRISVILLE,

27560

North Carolina

UNITED STATES