Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19954 |
| Brand Name: | Cook Inc Catheter, Angiography |
| Model: | |
| Affected: | all lots |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | Cook Group Inc |
| Brand Name: | Cook Inc Aprima Access Set |
| Model: | |
| Affected: | all lots |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | Cook Incorporated |
| Brand Name: | Cook Inc Transluminal Biliary Biopsy Forceps Set |
| Model: | |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | Cook Incorporated |
| Issue: | Manufacturer is initiating a recall of listed products as they have identified an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/ or separation. Preliminary investigation into this matter has identified that environmental conditions such as storage temperature, humidity and the use of Vapourised Hydrogen Peroxide for whole-room decontamination within healthcare facilities, may be contributing to this occurrence. Potential adverse events that may occur as a result if catheter polymer degradation coudl include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. (eg; device fragments in the vascular system, genitourinary system or other soft tissues). |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 27/4/2016 |
