Device Recall STATCheck

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.).

Lot Numbers: 313406, 313447, 313164, 313165 & 313166

Anesthesiology Devices

2

No

IL & OH distributors

STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1

Model #SC9000B, Lot #4034-10, 4047-07, 4064-10; Model #SC9000C, Lot #3295-03; Model #SC9001B, Lot #3290-03, 3309-22, 4047-05, 4064-11, 4071-13; Model #SC9001C, Lot #3290-04,3309-24, 3349-05, 4034-04.

Anesthesiology Devices

2

No

CA

STAT-Check, Adult Manual Emergency Resuscitator with A.C.E./STAT-Check CO¿ Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC 9000 Series, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX

Model #SC8001B, Lot #3295-01, 4063-02, Model #SC8021C, Lot #4054-04, Model #SC8121B, Lot #4040-01, Model #8121C, Lot #4047-06

Anesthesiology Devices

2

No

CA

STAT-Check, Pediatric Manual Emergency Resuscitator with A.C.E./STAT-Check CO¿ Indicator, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order SC-8000 Series, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX

Model #SC200, Lot #3254-03, 4020-01, 4040-09, 4043-05, 4056-05, 4063-07, 4064-20, 4078-03

Anesthesiology Devices

2

No

CA

A.C.E. STAT-Check CO¿ Indicator, Single, Single Patient Use, Non-Sterile, Rx only, Latex Free, Re-Order# SC200, Resuscitation ACE Corp., 155 Boyce Drive, Mocksville, NC 27028