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.
This recall has been terminated (originally issued June 28, 2011).
- Company
- Vbm Medical Inc.
- Recall Initiated
- May 9, 2011
- Posted
- June 28, 2011
- Terminated
- March 14, 2012
- Recall Number
- Z-2676-2011
- Quantity
- 29
- Firm Location
- Noblesville, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution -- USA ( nationwide ) including the country Montreal QC
Lot / Code Info
Lot number 28326
Root Cause
Error in labeling
Action Taken
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.