| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00835-1 |
| Product Name/Description |
Chorionic Villus Biopsy Needle Set
Catalogue Identifier: K-CVNS-1821-ROBINSON-ET
Order Number: G26661
All lots manufactured up to 4 June 2018
ARTG Number: 138806
(William A Cook Australia Pty Ltd - Chorionic Villi Biopsy Needle Set - Needle, biopsy, single use) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
26/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Cook Medical has identified the diagram on the product label of the Chorionic Villus Biopsy Needle Set (K-CVNS-1821-Robinson-ET) is incorrect. It shows that the 18GA needle has an echotip, and the 21GA needle does not, whereas the product is designed such that the 21GA needle has the echotip and the 18GA needle does not.
The tip of the larger gauge guide needle is likely to be visible on the ultrasound regardless of a non-echogenic tip. In the event that the labelling error resulted in a clinician expecting the echogenic tip to be present on the guide needle, instead of the sampling needle, the clinician may not be able to adequately identify the tip of the inserted access needle.
To date, there have been no reports of harm relating to this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
William A Cook is advising customers to inspect stock and return affected product.
This action has been closed out on 15/08/2019 |
| Contact Information |
1800 777 222 - Cook Medical Customer Relations |