Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01390-1
Product Name/Description Disposable Reuter Tip-Deflecting Wire Guide

Catalogue Identifier (Prefix/Suffix): DTDW-/-BH

Lot Numbers: F4791428, F4791430, NS5562947 and F4791427

Supplied under Special Access Scheme (SAS)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/11/2017
Responsible Entity William A Cook Australia Pty Ltd
Reason/Issue Cook Medical has identified that the labels of specific lots of Disposable Reuter Tip-Deflecting Wire Guides do not explicitly state that they are heparin coated. The products are labelled with the correct catalogue identifier, which includes the suffix “BH” that indicates the product is heparin coated. However, users who are not familiar with the “BH” nomenclature may not be aware that the product contains heparin.

To date, no adverse events have been reported due to this issue. Under rare circumstances, these products could unknowingly be used in a patient with a heparin allergy or a patient with a history of Heparin Induced Thrombocytopenia (HIT). Either of these situations could potentially result in serious injury or death.
Recall Action Recall
Recall Action Instructions Cook Medical is advising users to inspect stock and quarantine remaining units for replacement with unaffected stock.

This action has been closed out on 11/03/2021
Contact Information 1800 777 222 - Cook Medical