U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Air/oxygen face mask, rebreathing - Product Code BYG
원인
A sticky substance on the inside and/ or outside of the mask.
조치
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
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.
제품 설명
First Breath ¿ 3 in 1 Oxygen Mask with Reservoir Bag (1L) and Tubing, 213cm (7ft) (Non-latex) 50/CA || Re-Order Number: 001423 || 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