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U.S. Department of Health and Human Services

Class 2 Device Recall NonRebreather, Oxygen Mask

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 Class 2 Device Recall NonRebreather, Oxygen Masksee related information
Date Initiated by FirmMay 10, 2017
Date PostedMay 24, 2017
Recall Status1 Terminated 3 on August 27, 2021
Recall NumberZ-2238-2017
Recall Event ID 77282
Product Classification Mask, oxygen - Product Code BYG
ProductNon-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003
Code Information Lot Number (Product Code 3108-E) 100132, 104079, 105936; (Product Code 3108MM) 103715; (Product Code 86-106E) 100056, 101452, 101725, 102695, 103006, 104041, 104198, 104634, 104969, 105687; (Product Code 86-108E) 100057, 100200, 101453, 101726, 102080, 102477, 102566, 102696, 103005, 103549, 104042, 104199, 104450, 104694, 104847, 104971, 105596, 105688; (Product Code LM-86-106) 100138, 102215, 102866, 104160, 105169; (Product Code PMD06002) 100551; (Product Code PMD06003) 100550  
FEI Number 3011987967
Recalling Firm/
Manufacturer		 ConvaTec, Inc
7900 Triad Center Dr Ste 400
Greensboro NC 27409-9076
For Additional Information ContactDavid Pudwill
336-542-4753
FDA Determined
Cause 2		Process control
ActionRecall 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.
DistributionCA, 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 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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