Device Recall STA

Model SC9001B Adult STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask Lot numbers 303320 and 303612  Model SC9001C Adult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir & Mask Lot number 303400  Model SC9001C-C Adult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir, Mask & Straight Connector Lot numbers 303523 and 303791  Model SC8001B Pediatric STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask Lot number 303833

Anesthesiology Devices

2

No

Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.

STAT-Check Resuscitation Bag || Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer || Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel trained in CPR procedures. The ACE/STAT-Check II is intended for use as an adjunct assessment tool for verification of successful ventilation / intubation in patients > 2.2 kilograms (5lbs.).

Item: AB200, AB300, AB400, AB500 and AB700.

Dental Devices

2

Yes

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

Standard Abutment || Dental implants

Item: SQIC7

Dental Devices

2

Yes

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

Standard Abutment Pick -Up Coping || Dental implants

Item: TS250

Dental Devices

2

Yes

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

Standard Abutment Temporary Screw || Dental implants

Item: SIC70

Dental Devices

2

Yes

Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

Standard Abutment Transfer Coping || Dental implants