Recalls / —
—#155514
Product
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
- FDA product code
- CAT — Cannula, Nasal, Oxygen
- Device class
- Class 1
- Medical specialty
- Anesthesiology
- Affected lot / code info
- Product Code: 1101, Lot numbers: 74J1603122, 74K1601506, 74K1602306 and 74L16006.
Why it was recalled
Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
Root cause (FDA determination)
Unknown/Undetermined by firm
Action the firm took
Consignees were notified via letter on May 9, 2017.
Recalling firm
- Firm
- Teleflex Medical
- Address
- 2917 Weck Dr, Research Triangle Park, North Carolina 27709-0186
Distribution
- Distribution pattern
- CA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NY, NV, OH, PA, TX, VA, WI and WV.
Timeline
- Recall initiated
- 2017-05-09
- Terminated
- 2025-01-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #155514. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.