| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00928-1 |
| Product Name/Description |
Perifix Catheter Connector
Perifix Complete Set (Lor) Soft-Tip
Perifix One Complete Set
Perifix One Complete Set (Lor)
Espocan W. Ds + Pencan 27gx5 3/8" (0,42x
Espocan W. Ds + Pencan 27gx5 3/8" (0,42x
Espocan W. Ds + Pencan 27gx5 3/8" (0,42x
Perifix One Paed Set 18
Contiplex D Set,15°,18gx2 1/8", 1.3x55mm
Cont S Ult 360,20°18gx100mm-Cis/Ap/Eu/Sa
Cont. Tu. Ult 360,18gx100mm-Cis/Ap/Eu/Sa
Multiple Product Codes and Batch Numbers
ARTG Numbers: 143519, 144119 and 138970 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/07/2018 |
| Responsible Entity |
|
| Reason/Issue |
The Perifix Catheter Connector is a connection device used by clinicians to provide various anaesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anaesthetics. In the course of our regular post market surveillance activities we have found that the Perifix Catheter Connector may not remain closed during use. In some cases this has led to leakage or disconnection of the catheter from the Perifix Catheter Connector.
While no serious injuries to patients, users, or third parties have been reported to date, there is a possibility of contamination of the catheter or delay of anaesthesia of different severity. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Users are asked to:
Review the customer letter in its entirety and ensure that all users of these products in your organisation and other concerned persons are informed about this Medical Device Correction.
If you are a distributor, please forward the customer letter to your customers.
For continued safe use of the Perifix Catheter Connector, users are asked to review and follow the instructions described in Appendix 1 of the customer letter.
Confirm receipt of the customer letter by completing the supplied confirmation slip and return it as per the instructions given.
This issue has been superseded by RC-2019-RN-00113-1 |
| Contact Information |
1800 251 705 - B Braun Recall Coordinator |