Class 2 Device Recall Portex First Breath Adult Venturi Oxygen Mask with Corrugated Tubing,

• Date Initiated by Firm: February 11, 2011
• Date Posted: June 24, 2011
• Recall Status: Terminated on July 02, 2018
• Recall Number: Z-2655-2011
• Recall Event ID: 57906
• Product Classification: Air/oxygen face mask, venturi - Product Code BYF
• Product: First Breath Adult Venturi Oxygen Mask with Corrugated Tubing, O2 Diluter Jets (6), Oxygen Tubing, and Nebulizer Hood. (Non-latex) 50/CA Reorder Number: 002610 For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume
• Code Information: Lot Numbers: 09-50 10-04 10-05 10-06 10-07 10-10
• Recalling Firm/ Manufacturer: Smiths Medical; Hythe; Hythe, Kent United Kingdom
• Manufacturer Reason for Recall: A sticky substance on the inside and/ or outside of the Mask
• FDA Determined Cause: Nonconforming Material/Component
• Action: Smiths Medical notified consignees by letter on 2/14/11 titled Urgent Medical Device Correction Notice via U.S. Mail (USA only) This Notice includes an Urgent Medical Device Correction Notice Confirmation Form that provides instructions to consignees to return unused affected product to Smiths Medical and to complete the effectivity tracking form. On 3/17/11 Smiths Medical issued an additional recall letter to extend the recall to 3 additional lots not included in the original recall letter dated 2/14/11. Also, the firm issued a recall letter on 3/17/11 to include the Value Pack (VP1302) General Anesthesia Kit to include 7 kit lots. Contact Recall Coordinator 1-800-348-6064 prompt 4, ext 2273
• Quantity in Commerce: 14,700 units
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Armenia, Brazil, Canada, France, Hungary, Italy, Jordan, Japan, Libya, Poland, Russian Federation, and Saudi Arabia.
• 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.