Type of Product |
Medical Device |
TGA Recall Reference |
RC-2016-RN-01043-1 |
Product Name/Description |
Leongatha Delivery Pack containing umbilical clamps
Product number: 97047649-01 Umbilical clamps ref.: IFKR21 and 2305123-00 All batches are affected
ARTG Number: 133562 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
9/08/2016 |
Responsible Entity |
|
Reason/Issue |
Mölnlycke Health Care has become aware of situations where the umbilical clamp included in the ProcedurePak kits and trays may have been incorrectly used due to a lack of adequate instructions for use. If the clamp is used incorrectly i.e. both hooks in the clamp are not engaged, the clamp may reopen. If the clamp is not in place correctly when the umbilical cord has been cut, this can potentially lead to blood loss for the baby if not monitored regularly.
The IFU will be improved to include further instruction to ensure correct usage of the clamps. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Mölnlycke Health Care is providing users with the correct instructions for the umbilical clamp. To ensure correct usage:
- Rotate the umbilical cord clamp with the open side of the lock towards you, so that you can see the locking hooks. - Place the (thick) umbilical cord towards the ring end. - Both hooks must be correctly positioned, check carefully that both hooks are securely clicked into place. Incorrect engagement of the hooks can cause the clamp to open. This action has been closed-out on 17/02/2017. |
Contact Information |
02 8977 2114 - Mölnlycke Health Care |