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Terminated

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

FDA Recall Z-2653-2011 · Posted 2011-06-24

Recalling FirmSmiths Medical
Recall StatusTerminated
Product CodeBYG
Date Initiated2011-02-11
Date Terminated2018-07-02
Product Quantity600 units

Reason for Recall

A sticky substance on the inside and/ or outside of the Mask

Firm 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

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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