| 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 |
|
| 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 |