Recall Z-2675-2011 ยท BTO Tube, Tracheostomy (W/Wo Connector)
VBM Medical Inc.
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.
| Date | Jun 28, 2011 (initiated May 9, 2011) |
| Status | Terminated |
| 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 le |
| Quantity | 388 |
| Distribution | Worldwide Distribution -- USA ( nationwide ) including the country Montreal QC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955461 | TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). VBM Medizintechnik GmbH, Mar 19, 1997 |