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U.S. Department of Health and Human Services

Class 2 Device Recall Jet Ventilation Catheter (transtracheal)

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  Class 2 Device Recall Jet Ventilation Catheter (transtracheal) see related information
Date Initiated by Firm May 09, 2011
Date Posted June 28, 2011
Recall Status1 Terminated 3 on March 14, 2012
Recall Number Z-2675-2011
Recall Event ID 58807
510(K)Number K955461  
Product Classification Tube, tracheostomy (w/wo connector) - Product Code BTO
Product Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-914-1, VBM Medizintechnik GmbH, Einsteinstrasse 1 7212 Sulz a.N. Germany

Allows a safe and atraumatic transtracheal access for oxygenation/ventilation with a manual jet ventilator or an automatic high frequency jet ventilator.
Code Information Lot numbers 28327, 30067, 31065, 32642 and article number ACU 1060.2
Recalling Firm/
Manufacturer		 VBM Medical Inc.
524 Herriman Ct
Noblesville IN 46060-4363
For Additional Information Contact Alden or Tina Chen
317-776-1800
Manufacturer Reason
for Recall		 Product labeled with incorrectly as being appropriate for use in adults when the intended population for use of the product is children and infants.
FDA Determined
Cause 2		 Error in labeling
Action VBM Medical Inc sent an "URGENT FIELD SAFETY NOTICE" dated May 9, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The reference and lot numbers, details of the error, along with the incorrect and correct box label, and instructions to the customers to discard the box with the incorrect label or send the complete product back to VBM Medical Inc. for re-packaging. For any further or detailed questions, please contact VBM Medical Inc. at (317) 776-1800. On 7/12/11 upon receiving the recall classification letter, the firm sent out an additional letter to its direct accounts informing them of the recall's classification and reiterating the instructions listed above.
Quantity in Commerce 388
Distribution Worldwide Distribution -- USA ( nationwide ) including the country Montreal QC
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = BTO and Original Applicant = VBM MEDIZINTECHNIK GMBH
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