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.
FDA Recall Z-2675-2011 · Posted 2011-06-28
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Recalling FirmVBM Medical Inc.
Recall StatusTerminated
Product CodeBTO
Date Initiated2011-05-09
Date Terminated2012-03-14
Product Quantity388
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.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
Worldwide Distribution -- USA ( nationwide ) including the country Montreal QC
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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