Recall Z-2251-2017
Teleflex Medical · initiated May 9, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Codes / lots: Product Code: 1101, Lot numbers: 74J1603122, 74K1601506, 74K1602306 and 74L16006.
Reason for recall
Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
Consignees were notified via letter on May 9, 2017.
Details
- Recall number
- Z-2251-2017
- Initiated
- May 9, 2017
- Terminated
- January 16, 2025
- Product code
- CAT – Cannula, Nasal, Oxygen
- Quantity
- 1150 units
- Distribution
- CA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NY, NV, OH, PA, TX, VA, WI and WV.
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC