Aurous Centimeter Vessel Sizing Catheter

Aurous Centimeter Vessel Sizing Catheter Recall Cook Incorporated is recalling the Aurous Centimeter Vessel Sizing Catheter, a medical device used to measure blood vessels. The product is being recalled and must be returned to the supplier. The recall affects hospitals, pharmacies, and laboratories in New Zealand.

Recalling firm
Obex Medical Ltd
Product
Aurous Centimeter Vessel Sizing Catheter. [Device]. Model: CK-N5.0-35-100-P-10S-PIG-CSC-20 (CATHETER SIZING 5FR PIGTAIL NON BT). Affected: 16752732, 16813575, 16839886, 16858458, 16861720
Reason
This issue was identified internally during production. Following issue detection, product samples underwent tensile testing, where one sample cracked while being manipulated to load into the test fixture. While there is a quality control check in place to detect this failure mode prior to product release, all tested samples underwent this quality control check prior to being tested. This is indicative that the subject marker bands may fail at a point past the quality control check.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-04-07
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/20cd852b-6661-43e1-9b1c-f399b5e37edb