| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00645-1 |
| Product Name/Description |
Resus-EZY Manual Resuscitator (single-use pulmonary resuscitator)
Catalogue Numbers: HP-9511E, HP-9511F, HP-9511FL3, HP-9511FN, HP-9511PE, HP-9511PF, HP-9511Z, HP-9611OUEN
Batch Number: 061115
ARTG Number: 93870 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
There have been some reported cases where the Flow Diverter used in these products is being cracked. The Flow diverter is the blue adaptor that attaches to the Patient Valve. The Flow Diverter directs the patient’s exhaled breath to atmosphere or into a PEEP (Positive End Expiratory Pressure)Valve where a PEEP Valve is being used. A cracked Flow Diverter can affect the PEEP Valves ability to hold PEEP. As the Flow diverter is on the expiratory side of the breathing system there is no effect on the Resuscitators ability to deliver gas to the patient. Additionally, in the event of a cracked Flow Diverter, there are two discrete one way valves isolating the expiratory side from the Inspiratory side. Thus there is no pathway by which any foreign material could enter the inspiratory side of the resuscitator. A cracked Flow Diverter has no affect upon the Resuscitators ability to deliver gas to the patient. |
| Recall Action |
Recall |
| Recall Action Instructions |
Schell Medical is advising users to inspect stocks for the affected lot numbers. If any of the impacted products show signs of cracking, quarantine for return and replacement by Schell as per normal procedures. This action has been closed-out on 03/02/2017. |
| Contact Information |
1300 361 839 - Schell Medical Customer Service |