Recall Z-2251-2017 ยท CAT Cannula, Nasal, Oxygen
Teleflex Medical
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
| Date | May 9, 2017 |
| Status | Terminated |
| Reason | Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device. |
| Root cause | Unknown/Undetermined by firm |
| Action | Consignees were notified via letter on May 9, 2017. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.