Recall Z-1934-2013— Medtronic Xomed, Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Xomed, Inc., initiated 2013-07-09, terminated 2014-09-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.. Reason: The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY".
- Recalling firm
- Medtronic Xomed, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-09
- Terminated
- 2014-09-25
- Firm location
- Jacksonville, FL, United States
Product description
Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.
Reason for recall
The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY"
Data sourced from openFDA. This site is unofficial and independent of the FDA.