Recall Z-2010-2009 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Instrumentation Industries Inc
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.
| Date | Sep 3, 2009 (initiated Jul 9, 2009) |
| Status | Terminated |
| Reason | user instructions not updated to correspond with product change |
| Root cause | Component change control |
| 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. |
| Quantity | 396 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955461 | TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). VBM Medizintechnik GmbH, Mar 19, 1997 |