Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23859 |
| Brand Name: | W.O.M. WORLD OF MEDICINE GmbH - Distension unit, gas, laparoscopic |
| Model: | |
| Affected: | PneumoClear Humidification Refill Icon Discrepancy |
| Software version: | |
| Recalling Organisation: | Stryker New Zealand Ltd 515 Mount Wellington Highway Mount Wellington AUCKLAND 1060 |
| Contact Information: | 0800 787 9287 |
| Manufacturer: | WOM World of Medicine GmbH |
| Issue: | It was discovered by the project team that the Humidification Refill notification on the PneumoClear does not function as specified in the device's IFU. The humidification icon on the PneumoClear touchscreen remains green when actual flow is greater than an average of 8 L/min, even if there is not adequate fluid in the tubeset to sufficiently humidify gas to the level set forth in the design specification. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/11/2018 |
