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U.S. Department of Health and Human Services

Class 2 Device Recall Transtracheal (Jet Ventilation) Catheter ACU 1060.1

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 Class 2 Device Recall Transtracheal (Jet Ventilation) Catheter ACU 1060.1see related information
Date Initiated by FirmJuly 09, 2009
Date PostedSeptember 03, 2009
Recall Status1 Terminated 3 on October 15, 2009
Recall NumberZ-2010-2009
Recall Event ID 52898
510(K)NumberK955461 
Product Classification Tube, tracheostomy (w/wo connector) - Product Code BTO
ProductTranstracheal (Jet Ventilation) Catheter ACU 1060.1, labeled sterile if unopened. The Jet Ventilation Catheter allows a safe and atraumatic transtracheal access for oxygenation/ventilation.
Code Information 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.
Recalling Firm/
Manufacturer		 Instrumentation Industries Inc
2990 Industrial Blvd
Bethel Park PA 15102-2536
For Additional Information ContactDoris Walter
800-633-8577
Manufacturer Reason
for Recall		user instructions not updated to correspond with product change
FDA Determined
Cause 2		Component change control
ActionInstrumentation 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 Commerce396 units
DistributionNationwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = BTO
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