Flexicare - Non-rebreathing Mask
- Recalling firm
- Jackson Allison Medical and Surgical Ltd
- Product
- Flexicare - Non-Rebreathing Mask. [Device]. Model: 032-10-075NCNZ Flexicare Adult Non-Rebreathing Green Tinted Nose Clip Mask Head Strap Box/50 (26219001080). Affected: All Lot numbers
- Reason
- The affected device has been incorrectly labelled as a non-rebreathing mask. In practice, the mask functions as a rebreathing mask, as it does not include the required visible one-way valves over the side exhalation ports. These valves are essential components that prevent re-inhalation of exhaled gases in a true non-rebreathing system.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-03-03
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/7d52c702-f72a-4fe7-8a33-c8c2b654d154