FDA Recall
Terminated
Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation.
Recall: Z-2010-2009
·
Initiated July 9, 2009
Recall
- Recall Number
- Z-2010-2009
- Event Number
- 52898
- Firm
- Instrumentation Industries Inc
- FEI Number
- 2518436
- Product Code
- BTO
- Status
- Terminated
- Root Cause
- Component change control
- Initiated
- July 9, 2009
- Posted
- September 3, 2009
- Terminated
- October 15, 2009
- Address
- 2990 Industrial Blvd, Bethel Park, PA, 15102-2536
Description
Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation.
Reason
user instructions not updated to correspond with product change
Action
Instrumentation Industries, Inc. issued a notification letter dated July 9, 2009 to their customers explaining the problem and the need to replace current inventory user instructions with the revised user instructions accompanying the letter. For further questions, contact Instrumentation Industries, Inc. at 1-800-633-8577.
Distribution
Nationwide Distribution -- AK, AL, AR, CA, CO, FL, GA, IA, ID, IL,IN, MA, MD, ME, MI, MN, NC, ND, NH, NJ, OH, PA, SC, SD, TX, VA and WA.
Quantity
396 units