| TGA Action ID |
RC-2026-RN-00557-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Disposable Infant Resuscitation Circuit
Catalogue Number: TB2000
Batch Numbers: TB2000-0558, TB2000-0560, TB2000-0562
Expiry Dates: 01/2029, 02/2029, 03/2029
Catalogue Number: TB2000-A
Batch Number: TB2000-A/0063
Expiry Date: 03/2029
Catalogue Number: TB2000-RM1
Batch Number: TB2000-RM1/0048
Expiry Date: 05/2029 |
| ARTG Number |
418077 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Parker Healthcare has identified certain batches of the Disposable Infant Resuscitation Circuits (REF: TB2000) may not achieve the intended Positive End Expiratory Pressure (PEEP) at the specified oxygen flow rates. This may result in lower-than-expected PEEP being delivered during use and can result in inadequate lung inflation, reduced oxygenation, and increased work of breathing. All affected batches are being recalled while the problem is investigated.
No adverse health consequences have been reported in relation to this problem. |
| Instructions for Customers/Users |
Customers are to:
· Identify affected stock on hand and quarantine immediately to prevent further use.
· Parker Healthcare will arrange the collection of affected stock and a replacement will be provided. |
| Action Commencement Date |
23/07/2026 |
| Responsible Entity |
|
| Contact Information |
03 9872 0222 - Parker Healthcare |