FDA Recall
Terminated
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Recall: Z-2251-2017
·
Initiated May 9, 2017
Recall
- Recall Number
- Z-2251-2017
- Event Number
- 77230
- Firm
- Teleflex Medical
- FEI Number
- 3005747797
- Product Code
- CAT
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- May 9, 2017
- Terminated
- January 16, 2025
- Address
- 2917 Weck Dr, Research Triangle Park, NC, 27709-0186
Description
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.
Action
Consignees were notified via letter on May 9, 2017.
Distribution
CA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NY, NV, OH, PA, TX, VA, WI and WV.
Quantity
1150 units