Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37630 |
| Brand Name: | Alaris System Infusion Pumps_CFN San Diego |
| Model: | BD Alaris™ Point of Care Unit (PCU) |
| Affected: | Software - 12.1.1 |
| Software version: | |
| Recalling Organisation: | Becton Dickinson Ltd Unit 4 / 110 Mays Road Onehunga Auckland 1061 |
| Contact Information: | 0800 572 468 |
| Manufacturer: | CareFusion 303 Inc |
| Issue: | The manufacturer has identified that the device labelling does not indicate which Transport Layer Security (TLS) versions must be enabled on the hospital network to ensure secure Wi-Fi communication with the AlarisTM and BD Alaris™ Point-of-Care Unit (PCU) when using enterprise-level Wi-Fi security. Without clear labelling, hospitals may unknowingly disable TLS 1.0, resulting in network connectivity failure and memory leaks which could lead to potential System Error. Alaris™ and BD Alaris™ PCUs (v12.1.1 and prior) are not compatible with TLS security frameworks beyond TLS 1.0. If TLS 1.0 is disabled on the customer network, the PCUs will fail to connect to the wireless network. For customers utilising bi-directional workflow, this leads to interoperability failures which require users to manually program devices. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/9/2026 |
