Recall Z-2251-2017— Teleflex Medical
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical, initiated 2017-05-09, terminated 2025-01-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,. Reason: Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device..
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-09
- Terminated
- 2025-01-16
- Firm location
- Research Triangle Park, NC, United States
Product description
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Reason for recall
Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.