FDAFDA · Food and drugs·Recall number Z-2251-2017
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Published June 14, 2017 · Recall initiated: May 9, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- CA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NY, NV, OH, PA, TX, VA, WI and WV.
- Lot
- Product Code: 1101, Lot numbers: 74J1603122, 74K1601506, 74K1602306 and 74L16006.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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