FDAClass IIJune 14, 2017

Hudson RCI recall: Labeling Error

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

Why was Hudson RCI recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Recalling firm
Teleflex Medical
Quantity
1150 units
Distribution
CA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NY, NV, OH, PA, TX, VA, WI and WV.
Recall date
June 14, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls