| TGA Action ID |
RC-2025-RN-00336-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Flexi Port Reusable Blood Pressure Cuffs and Two-Piece Reusable Blood Pressure Cuffs kits
Multiple products, product codes and UDI's
ARTG 141049, 362870, 375318 |
| ARTG Number |
141049 |
| Unique Device Identifier (UDI) |
See Attachment A |
| Action Type |
Recall |
| Action Level |
Consumer |
| Hazard Classification |
Class I |
| Reason for the Action |
The product is labelled “not made with natural rubber latex,” however, a latex-containing rubber band is located around the product instructions for use (IFU).
Baxter stated that this problem could potentially affect those with latex allergies causing various symptoms such as rash, itching, swelling, sneezing, and anaphylaxis. Even minimal exposure to residual latex protein can trigger a reaction.
There have been no reported injuries related to this problem from Baxter. |
| Instructions for Customers/Users |
Customers are to:
- Immediately locate unopened impacted products at their facility (further instructions on how to identify affected stock is in the customer letter).
Return any affected unopened blood pressure cuffs in their packaging.
- Contact Baxter Technical Support to arrange for return and exchange on 1800 445 576. |
| Action Commencement Date |
3/04/2025 |
| Responsible Entity |
|
| Contact Information |
1800 445 576 - Baxter Healthcare |