Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-918-1, VBM Medizintechnik GmbH, Einsteinstrasse 1
FDA device recall Z-2676-2011 · posted 2011-06-28 · Terminated
Recall details
- Recalling firm
- VBM Medical Inc.
- 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.
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- BTO
- Quantity affected
- 29
- Distribution
- Worldwide Distribution -- USA ( nationwide ) including the country Montreal QC
- Date initiated
- 2011-05-09
- Date posted
- 2011-06-28
- Date terminated
- 2012-03-14
- Location
- Noblesville, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). (K955461) | VBM Medizintechnik GmbH | 1997-03-19 |