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U.S. Department of Health and Human Services

Class 2 Device Recall Hudson RCI Pediatric Nasal Cannula

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 Class 2 Device Recall Hudson RCI Pediatric Nasal Cannulasee related information
Date Initiated by FirmMay 09, 2017
Create DateJune 07, 2017
Recall Status1 Open3, Classified
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.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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