Device product
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Z-2251-2017
Product summary
- Firm
- Teleflex Medical
- Event
- Event 77230
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1150 units
- Official record key
device-enforcement:Z-2251-2017
Official wording
Reason: Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
Code information: Product Code: 1101, Lot numbers: 74J1603122, 74K1601506, 74K1602306 and 74L16006.
Distribution pattern: CA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NY, NV, OH, PA, TX, VA, WI and WV.
Derived failure modes
-
Labeling or packaging
Incorrect labeling