| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00138-1 |
| Product Name/Description |
AQUAPAK BRITISH and INTL 340 SW, 340 ML W/040B Humidifier Adaptors
Catalogue number: 400340
Batch Numbers: 149137, 307137, 362137, 385137
Catalogue number: 003-40B
Batch Numbers: 312137, 394137, 396137, 429137
Catalogue Number: 400360
Batch Number: 91136
ARTG Number: 215829 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Teleflex Medical is recalling the products listed due to a possibility that the packages may contain foreign material, (predominantly synthetically derived PVC). This foreign matter has only been found in the package and not in the gas flow path of the humidifier product. If the foreign matter particles migrate into the sterile water reservoir, or enter the connecting tubing between the reservoir and the patient, the particle could potentially enter the patient airway at very high gas flows and could cause the hazard of mild lung discomfort, which is usually temporary and reversible. |
| Recall Action |
Recall |
| Recall Action Instructions |
A Teleflex representative will contact hospitals and medical centres to arrange for the affected devices to be inspected. Any units with foreign material will be recalled. If there is no visible foreign matter the product is safe to use. Unaffected batches are not expected to be available until May 2015. This action has been closed-out on 31/05/2016. |
| Contact Information |
1300 360 226 - Teleflex Medical |