Recall Z-2653-2011 ยท BYG Mask, Oxygen
Smiths Medical
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
| Date | Jun 24, 2011 (initiated Feb 11, 2011) |
| Status | Terminated |
| Reason | A sticky substance on the inside and/ or outside of the Mask |
| Root 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) G |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.