Class 2 Device Recall Oxygen Mask

• Date Initiated by Firm: May 10, 2017
• Date Posted: May 24, 2017
• Recall Status: Terminated on August 27, 2021
• Recall Number: Z-2231-2017
• Recall Event ID: 77282
• Product Classification: Mask, oxygen - Product Code BYG
• Product: Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM
• Code Information: Lot Number 100721, 100733, 104106, 104798, 109824
• Recalling Firm/ Manufacturer: ConvaTec, Inc; 7900 Triad Center Dr Ste 400; Greensboro NC 27409-9076
• For Additional Information Contact: David Pudwill; 336-542-4753
• FDA Determined Cause: 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

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.