Z-2251-2017Class II

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

Name: Z-2251-2017 Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only
Creator: Teleflex Medical
Published: 2017-05-09
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2017-05-09 / Terminated / root cause: labeling and UDI

FDA source

Teleflex Medical began a recall of Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only on 2017-05-09. FDA classified it as Class II and gives the reason as "Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2251-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-09
Posted: 2017-06-07
Terminated: 2025-01-16
Recalling firm: Teleflex Medical
Product: Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Product code: CAT Cannula, Nasal, Oxygen
Reason for recall: Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: Consignees were notified via letter on May 9, 2017.
Quantity in commerce: 1150 units
Distribution: CA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NY, NV, OH, PA, TX, VA, WI and WV.
Product codes and lots: Product Code: 1101, Lot numbers: 74J1603122, 74K1601506, 74K1602306 and 74L16006.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2251-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2251-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-07

Product code CAT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)