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U.S. Department of Health and Human Services

Class 2 Device Recall Oxygen Masks, Elongated

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  Class 2 Device Recall Oxygen Masks, Elongated see related information
Date Initiated by Firm May 10, 2017
Date Posted May 24, 2017
Recall Status1 Terminated 3 on August 27, 2021
Recall Number Z-2228-2017
Recall Event ID 77282
Product Classification Mask, oxygen - Product Code BYG
Product Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Code Information Lot Number 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530
Recalling Firm/
Manufacturer		 ConvaTec, Inc
7900 Triad Center Dr Ste 400
Greensboro NC 27409-9076
For Additional Information Contact David Pudwill
336-542-4753
Manufacturer Reason
for Recall		 Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. The failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. While the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.
FDA Determined
Cause 2		 Process control
Action Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.
Quantity in Commerce 816,709
Distribution CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam
Total Product Life Cycle TPLC 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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