| TGA Action ID |
RC-2026-RN-00748-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Various Procedure Packs containing BAG DRAWSTRING DUAL CORD 46X50CM
Bag Component Code: 95549
Procedure Pack Description: Donor Pack, Basic Retrieval Set, Milling Pack 10, Cadaveric Pack
Procedure Pack codes: SBASYWM01A, SOPPEPB02P, SOPPEPB05F, SOPPEPB06D
All Lots manufactured before 01/10/26 |
| ARTG Number |
137395 |
| Unique Device Identifier (UDI) |
09336654110354, 09336654115786, 09336654110590, 09336654110729, 09336654115687 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
A complaint was received where the component bag intended for organ storage within a Donor Pack had leaked. Medline has identified that this specific drawstring bag is not fit for the intended purpose of storing organs and bones for re-use.
There is the potential risk that the retrieved organs and bones may not remain viable. |
| Instructions for Customers/Users |
Option 1:
- Customers can open the procedure pack, remove and quarantine the Drawstring Bags.
- Continue to use the remaining items in the procedure pack.
- A Medline Account Manager will contact customers regarding the disposition of the Drawstring Bags, and a credit will be provided.
- If necessary for the procedure, utilise other suitable bags.
Option 2:
- Quarantine all affected procedure packs.
- A Medline Account Manager will contact customers regarding the disposition of the procedure packs, and a credit will be provided. |
| Action Commencement Date |
30/09/2026 |
| Responsible Entity |
|
| Contact Information |
1800 110 511 - Medline International Two Australia Customer Service |