Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:26930
Brand Name:Flexor Introducer Sets
Model:
Affected:Multiple 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
Issue:The manufacturer has identified that there is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:26/11/2020
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