| TGA Action ID |
RC-2025-RN-00492-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Rocket Copeland Fetal Scalp Electrode
Product Code: R57008-00-FM
Lot Numbers: 503459, 503458, 503457, 503329, 503328, 500028, 499185
Product Code: R57008-00-CN
Lot Numbers: 503557, 499108 |
| ARTG Number |
173110 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Revision 16 of ZDOCK167, the Instructions For Use (IFU) of the Fetal Scalp Electrodes is missing the following Warning and Cautions. These were present in previous revisions of the IFU but were erroneously removed from Revision 16.
WARNING: Chronic fetal bleeding (e.g., due to partial placental abruption) leading to loss of fetal blood volume, may compromise the fetus’s ability to successfully respond to hypoxia.
CAUTION: Do not rely on the spring tension to insert the needle into the skin.
CAUTION: Device performance and safety has not been verified for use in water births. The device must not be immersed in water.
CAUTION: If there is severe maternal thrombocytopaenia, any decision to use the fetal scalp electrode should be taken carefully, considering the potential risks and benefits, and taking account of clinical guidelines. In case of accidental maternal injury from the electrode, or if the fetus is affected, there may be increased bleeding, bruising or abnormal blood clotting. |
| Instructions for Customers/Users |
Ensure a copy of the customer letter and the updated IFU is available to all users or potential users of this device.
This action has been closed out on 14/10/2025. |
| Action Commencement Date |
27/05/2025 |
| Responsible Entity |
|
| Contact Information |
0431 146 448 - Rocket Medical |