Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
This recall has been terminated (originally issued May 9, 2017).
- Company
- Teleflex Medical
- Recall Initiated
- May 9, 2017
- Terminated
- January 16, 2025
- Recall Number
- Z-2251-2017
- Quantity
- 1150 units
- Firm Location
- Research Triangle Park, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
Distribution
CA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NY, NV, OH, PA, TX, VA, WI and WV.
Lot / Code Info
Product Code: 1101, Lot numbers: 74J1603122, 74K1601506, 74K1602306 and 74L16006.
Root Cause
Unknown/Undetermined by firm
Action Taken
Consignees were notified via letter on May 9, 2017.
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