| TGA Action ID |
RC-2026-RN-00512-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
3M Comply Lead Free Steam Indicator Tape 1322-24MM and 1322-18MM
Lot Number: 251106 (distributed between December 10, 2025 through June 4, 2026)
Expiry Date: 06/05/2027 |
| ARTG Number |
126362 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
KCI Medical (Solventum) has determined that this lot of steam indicator tape may contain rolls without indicator ink present due to a manufacturing printing non-conformance. If the indicator tape roll does not contain indicator ink, the product will not provide visual distinction between processed and unprocessed units. The volume of potentially impacted rolls within the identified lot is low.
There is no safety concern and there are no reported injuries associated with this problem. |
| Instructions for Customers/Users |
Distributors are to:
- Immediately cease distribution of the affected lot of 3M Comply Lead Free Steam Indicator Tape.
-- Notify all customers who have purchased the affected product using the Customer Letter with Customer Response Form provided.
- Complete the Distributor Response Form and email the completed form and credit request to anzfieldaction@solventum.com.
Customers are to:
- Immediately cease use of the affected lot of 3M Comply Lead Free Steam Indicator Tape.
- Complete the Customer Response Form and email the completed form to the distributor, cc: anzfieldaction@solventum.com. |
| Action Commencement Date |
7/07/2026 |
| Responsible Entity |
|
| Contact Information |
1300 363 878 - Solventum Customer Service |