Ventilator Circuit For Non-invasive Ventilation
- Recalling firm
- Active Rehab Equipment
- Product
- Ventilator circuit for non-invasive ventilation. [Device]. Model: Product Code - AMVC1792-156. Affected: Lot numbers 021025, 181024
- Reason
- The manufacturer investigation of the customer reports did not identify any anomaly or non-conformance with the product as all devices were manufactured to the specifications set. The existing IFU requires an update to prevent reasonable forseeable misuse when handling the device., Pulling on the tubing may lead to inadvertent tubing separation from the purple cuff connector. Replacement of the circuit may result in delays in treatment and will require intervention by Healthcare Professional. These situations present a potential risk of respiratory distress, hypoxia, and/or low oxygen...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-02-16
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/278d2bd7-683c-4183-aecb-cf1ab9b9a710