| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00140-1 |
| Product Name/Description |
3M Tube Securement Device
Catalogue Number: 1500U
Lot Numbers: 33TNNN, 33TNMH, 33KNWC, 33KNJD, 33KND8
Catalogue Number: 1501U
Lot Numbers: 33TNH3, 33TNDC
ARTG 393430
(3M Australia Pty Ltd - Intravenous catheter holder) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/02/2024 |
| Responsible Entity |
|
| Reason/Issue |
During a recent investigation, 3M confirmed the presence of some manufacturing nonconformities within select lots of the 3M Tube Securement Device, Catalogue Numbers 1500U and 1501U.
The affected devices may have the top film layer of the device partially or completely missing. Additionally, some devices may exhibit the appearance of an incorrect shape due to excess material not being removed from the product liner.
These devices may impact the ability to secure tubes as intended, which may increase the risk for tube dislodgement.
This product has been registered in Australia but not commercially launched. However, some customers have been sent a sample of the registered product for evaluation.
No injuries have been reported associated with this issue to date. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are required to:
-Immediately discontinue use of affected lots of the product and quarantine it for destruction.
-Request credit for the destroyed product by contacting 3M Health Care Customer Helpline or by emailing 3MANZfieldsafetyaction@mmm.com. |
| Contact Information |
1300 363 878 - 3M Health Care Customer Helpline |