Z-2675-2011

Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-914-1, VBM Medizintechnik GmbH...

Name: Z-2675-2011 Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-914-1, VBM Medizintechnik GmbH...
Creator: VBM Medical Inc.
Published: 2011-05-09
License: https://open.fda.gov/license/

VBM Medical Inc. / initiated 2011-05-09 / Terminated / root cause: labeling and UDI

FDA source

VBM Medical Inc. began a recall of 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... on 2011-05-09. The reason FDA records is "Product labeled with incorrectly as being appropriate for use in adults when the intended population for use of the product is children and infants". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2675-2011
Status: Terminated
Initiated: 2011-05-09
Posted: 2011-06-28
Terminated: 2012-03-14
Recalling firm: VBM Medical Inc.
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.
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
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.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: Lot numbers 28327, 30067, 31065, 32642 and article number ACU 1060.2

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)