| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01577-1 |
| Product Name/Description |
TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP
Batch / Lot Number: TB2000-0141
ARTG Number: 188097 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
During investigation of the reported complaints from the field, the manufacturer has identified that there is a potential for some circuits of the affected batch to operate incorrectly. The 10 mmF connector of the circuits was slightly oversized during its manufacturing and therefore the device could become loose from the Fisher & Paykel NeoPuff’s 10 mmM connector under certain pressure and would not deliver the required pressure to the patient. |
| Recall Action |
Recall |
| Recall Action Instructions |
All remaining TB2000 circuits from the affected Batch TB2000-0141 will be replaced with unaffected batches without any additional costs to the customer. Customers are advised to isolate the affected units and contact Parker Healthcare Customer Service Department or their sales representative to organise the return of the recalled stock and to get replacement stock. This action has been closed-out on 26/05/2017. |
| Contact Information |
03 9872 0222 - Parker Healthcare Quality Officer |