RecallRadar

FDA Device recall Z-2251-2017

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

On 2017-06-14 the FDA classified a Class II recall of Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only by Teleflex Medical, citing incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2251-2017
ClassificationClass II
Statusterminated
Initiated2017-05-09
Published2017-06-14
Last updated2026-09-13 11:54 UTC
CompanyTeleflex Medical
DistributionCA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, PA, TX, VA, WI, WV

Product

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.

Identifiers

code_infoProduct Code: 1101, Lot numbers: 74J1603122, 74K1601506, 74K1602306 and 74L16006.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2251-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.