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U.S. Department of Health and Human Services

Class 3 Device Recall smiths medical portex First Breath Adult Nasal Cannula

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 Class 3 Device Recall smiths medical portex First Breath Adult Nasal Cannulasee related information
Date Initiated by FirmJuly 06, 2018
Create DateOctober 05, 2018
Recall Status1 Terminated 3 on April 30, 2019
Recall NumberZ-0073-2019
Recall Event ID 80635
Product Classification Cannula, nasal, oxygen - Product Code CAT
Productsmiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
Code Information Lot numbers 1703171A and 1705152A
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
Manufacturer Reason
for Recall		"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
FDA Determined
Cause 2		Labeling design
ActionThe recalling firm issued an Urgent Medical Device Recall letters dated July 6, 2018 via UPS tracked hard-copy mailing The letter identified the affected product, problem and actions to be taken. Customers were requested to return affected products using the enclosed shipping label. For questions email Stericycle at SmithsMedical7434@stericycle.com.
Quantity in Commerce3,000 devices
DistributionWorldwide Distribution - US Nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ, NV, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Poland and Russia.
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.
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