Z-2010-2009

Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation...

Name: Z-2010-2009 Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation...
Creator: Instrumentation Industries Inc
Published: 2009-07-09
License: https://open.fda.gov/license/

Instrumentation Industries, Incorporated / initiated 2009-07-09 / Terminated

FDA source

Instrumentation Industries Inc began a recall of Transtracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation Catheter allows a safe and atraumatic transtracheal... on 2009-07-09. The reason FDA records is "user instructions not updated to correspond with product change". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2010-2009
Status: Terminated
Initiated: 2009-07-09
Posted: 2009-09-03
Terminated: 2009-10-15
Recalling firm: Instrumentation Industries, Incorporated
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.
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
Reason for recall: user instructions not updated to correspond with product change
FDA 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 in commerce: 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.
Product codes and lots: 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.

Product code BTO

K955461Class IITranstracheal Catheter (Acc. Ravussin).VBM Medizintechnik GmbH / cleared 1997-03-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)