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