E.N.T. PK 7/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
EAR PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
EAR PACK 3/CS || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
EENT PACK I (1) 10/CS CUSTOMED || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. || .
Catalog Number: 9001482 || ENT SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Worldwide Distribution-US (nationwide) and countries of: Albania, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Oman, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, and United Kingdom.
Descripción del producto
Rigid Laryngostroboscopes || The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
Part No. 31-55631, lot number 27066500 Part No. 31-55632, lot number 27111700 Part No. 31-55642, lot number 27135800 Part No. 31-55647, lot number 27123300
Product was distributed to hospitals in the follwoing US states: CO, VA, MA, CA, HI, ID, VT, NY, NC, OK, MO, TX, GA, AND AL. there were no military or government accounts. There were nine international accounts as follows (all distributors): 1- Kir-Op AS, Biskop Jens Nilssonsgt 5A, Postal Box 6631 Etterstad 0607 Oslo, Norway. 2- Kebo Care Dema, Jerholmen 41, DK 2650 Hvidovre Denmark 3- Biomedical Technology, Via Tolstoi 7, 20090 Trezzano Sul, Nabiglio, Milan Italy. 4-Apex Medical Est. Jawad Sikkarieh Bldg., Sweifeh Amman 111121, PO Box 213131 Jordan 5- Diseven, Carrera 12 No 102-07 Santafe de Bogota Colombia; 6- Wise Horse, 10F-1 No. 11, Minchuan, Taipei, Taiwan 7- Medtronic Xomed, Unit 2/446 Victoria Road, Gladesville NSW Australia 8- Medtronic Xomed France, Saint Aubin Le Monial, 03160 Bourbon L''Archambault France 9- Medtroni BV Earl Bakenstraat 10, 6422 P J Heerlen, PO BNox 25880 6401 Db Heerlen, The Netherlands
Descripción del producto
Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar labeling as follows: || Part Number 31-55631 Oto-Flex carbide 1.0mm Bur; || Part Number 31-55632 Oto-Flex carbide 2.3mm Bur; || Part Number 31-55642 Oto-Flex diamond 2.3mm Bur; || Part Number 31-55647 Oto-Flex diamone 0.7 mm Bur || PART NUMBER AND LOT NUMBER IS LISTED ON POUCH AND BOX LABEL.
The product was released for distribution to 15 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the direct accounts (users) who received the recalled product. There is one Veterans Affairs account: Dept. of Veterans Affairs Medical Center PA, 1 215 823-4659, University & Woodland Avenues, Philadelphia, PA 19104, USA
Descripción del producto
Acclarent brand Relieva Sinus Inflation Device Kit; || Model BID30; The kit contains 1 inflation device, 1-10'' extension tube, 1-20cc syringe, 3-way stop-cock; Manufactured for Acclarent, Inc., 1525-B O''Brien Dr., Menlo Park, CA 94025
Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. || Product Usage: Sinus washing device to keep sinus passages clear of congestion.
Worldwide distribution: USA (nationwide) including states of: AR, CA, FL,GA, IL, LA, MA, MI, MO, NC, NH, NY, OH, OK, PA, RI, SE,TX, and WA; and countries of: AUSTRALIA, BARCELONA, GERMANY, NEW ZEALAND, NETHERLANDS, SWITZERLAND, and UNITED KINGDOM.
Descripción del producto
Vital Signs Disposable General Purpose 9 French Temperature Probe || For monitoring of core temperature
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Descripción del producto
Laryngo Stroboscope || Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx, Pharynx and Vocal Cords. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.