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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Instrumentation Industries Inc
Lot Codes / Batch Numbers
Lot Numbers: P0207409, P0209509, P0211009, P0214009, P0215609, P0301609, P0303109, P0304909, P0306209, P0307909, P0312309, P0400209, P0402409, P0404409, P0405909, P0408509, P0410009, P0412209, P0414209, P0416909, P0506509, P0506509R09, P0507609, P0509709, P0515009, P0602309, P0602809, P0604009, P0604209, P0607009, P0607009, P0607009R09, P0608809, P0612309, P0613709, P0615809, P0617309 and P0619209.
Products Sold
Lot Numbers: P0207409, P0209509, P0211009, P0214009, P0215609, P0301609, P0303109, P0304909, P0306209, P0307909, P0312309, P0400209, P0402409, P0404409, P0405909, P0408509, P0410009, P0412209, P0414209, P0416909, P0506509, P0506509R09, P0507609, P0509709, P0515009, P0602309, P0602809, P0604009, P0604209, P0607009, P0607009, P0607009R09, P0608809, P0612309, P0613709, P0615809, P0617309 and P0619209.
Instrumentation Industries Inc is recalling Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilati due to user instructions not updated to correspond with product change. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
user instructions not updated to correspond with product change
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026