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U.S. Department of Health and Human Services

Class 2 Device Recall Portex First Breath Adult Face Tent (Nonlatex)

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  Class 2 Device Recall Portex First Breath Adult Face Tent (Nonlatex) see related information
Date Initiated by Firm February 11, 2011
Date Posted June 24, 2011
Recall Status1 Terminated 3 on July 02, 2018
Recall Number Z-2653-2011
Recall Event ID 57906
Product Classification Medication therapy tent, adult - Product Code BYG
Product First Breath ¿ Adult Face Tent (Non-latex) 50/CA
Reorder Number: 001490
Face Tent Is a special type of aerosol mask used when the delivery of oxygen is not the primary objective. Normally this type of mask is used to deliver an aerosol mist to cool and moisturize the nasal passages or sinuses after surgery
Code Information Lot Numbers:  10-11
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 2		 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 600 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.
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