PlainRecalls
FDA Devices Moderate Class II Terminated

Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,

Reported: June 14, 2017 Initiated: May 9, 2017 #Z-2251-2017

Product Description

Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,

Reason for Recall

Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.

Details

Recalling Firm
Teleflex Medical
Units Affected
1150 units
Distribution
CA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NY, NV, OH, PA, TX, VA, WI and WV.
Location
Research Triangle Park, NC

Frequently Asked Questions

What product was recalled?
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,. Recalled by Teleflex Medical. Units affected: 1150 units.
Why was this product recalled?
Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 14, 2017. Severity: Moderate. Recall number: Z-2251-2017.