FDA Medical Device Recalls (openFDA)
VBM Medical Inc.: Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-918-1, VBM Medizintechnik GmbH, Einsteinstrasse 1 7212 Sul z 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.
- Recall number
- Z-2676-2011
- Recalling firm
- VBM Medical Inc.
- Product
- Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-918-1, VBM Medizintechnik GmbH, Einsteinstrasse 1 7212 Sul z 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.
- Status
- Terminated
- Initiated
- 2011-05-09
- Posted
- 2011-06-28
- Terminated
- 2012-03-14
- Reason
- 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
- 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
- 29
- Distribution
- Worldwide Distribution -- USA ( nationwide ) including the country Montreal QC
- Lot, serial or model codes
- Lot number 28326
- 510(k) numbers
- ["K955461"]
- PMA numbers
- not on file
- Product code
- BTO
- Firm FEI
- 3003316541
- Firm city
- Noblesville
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28