First Breath Adult Aerosol Mask (Non-latex) 50/CA Reorder Number: 001426 Oxygen/Aerosol Mask 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
This recall has been terminated (originally issued June 24, 2011).
- Recall Initiated
- February 11, 2011
- Posted
- June 24, 2011
- Terminated
- July 2, 2018
- Recall Number
- Z-2649-2011
- Quantity
- 5350 units
- Official Source
- View on FDA website ↗
Reason for Recall
A sticky substance on the inside and/ or outside of the Mask
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.
Lot / Code Info
Lot Numbers: 10-04 10-08 10-17
Root Cause
Nonconforming Material/Component
Action Taken
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