Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Hudson RCI Pediatric Nasal Cannula

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Hudson RCI Pediatric Nasal Cannulasee related information
Date Initiated by FirmMay 09, 2017
Create DateJune 07, 2017
Recall Status1 Terminated 3 on January 16, 2025
Recall NumberZ-2251-2017
Recall Event ID 77230
Product Classification Cannula, nasal, oxygen - Product Code CAT
ProductHudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Code Information Product Code: 1101, Lot numbers: 74J1603122, 74K1601506, 74K1602306 and 74L16006.
FEI Number 3005747797
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information ContactElizabeth Norwood
919-544-8000 Ext. 68487
Manufacturer Reason
for Recall		Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionConsignees were notified via letter on May 9, 2017.
Quantity in Commerce1150 units
DistributionCA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NY, NV, OH, PA, TX, VA, WI and WV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-