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Class 2 Device Recall NonRebreather Mask w 7 (2.1 m) NoCrush Tubing |
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Date Initiated by Firm |
May 10, 2017 |
Date Posted |
May 24, 2017 |
Recall Status1 |
Terminated 3 on August 27, 2021 |
Recall Number |
Z-2244-2017 |
Recall Event ID |
77282 |
Product Classification |
Mask, oxygen - Product Code BYG
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Product |
Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA |
Code Information |
Lot Number (Product Code 9106-E) 100168, 101193, 101896; (Product Code 9108-E) 102143, 103119, 103378, 104273, 104839, 104879, 105224; (Product Code ZRNRMA) 101060, 103355, 104768, 105655 |
Recalling Firm/ Manufacturer |
ConvaTec, Inc 7900 Triad Center Dr Ste 400 Greensboro NC 27409-9076
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For Additional Information Contact |
David Pudwill 336-542-4753
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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. |
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
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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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