Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation Catheter allows a
FDA device recall Z-2010-2009 · posted 2009-09-03 · Terminated
Recall details
- Recalling firm
- Instrumentation Industries Inc
- Reason for recall
- user instructions not updated to correspond with product change
- Action taken
- 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.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- BTO
- Quantity affected
- 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.
- Date initiated
- 2009-07-09
- Date posted
- 2009-09-03
- Date terminated
- 2009-10-15
- Location
- Bethel Park, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). (K955461) | VBM Medizintechnik GmbH | 1997-03-19 |