Reported Aug 21, 2013 · Terminated
Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments…
Medtronic Xomed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Xomed, Inc. · 6743 Southpoint Dr N · Jacksonville, FL · 32216-6218
Is this the product you have?
- 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.
- Lot codes and dates
14 of 14 products
Products covered by this recall Model / number Product as published 3717000= 2 Level Instrument tray 3717001= 3 Level tray (metal & radel) 3717006= 2 Level Instruument tray with mat 3717026= House Otology Set tray 3722301= Wiet Chronic Ear Set tray 3747108= Skykes Endobrow Lift tray 960374= framelock tray Model *960-811 = Framelock Instrument set (includes tray 9603740 960-619= LandmarX tray Model *9731372XOM1 = Passive ENT Instrument Set (w/tray 960-619) MCOH0SC= Otology Plastic instrument tray MCO649SC= Middle Ear Instrument tray MCOS10SC= Instrument tray 2 level MCLS28= MF Sataloff Complete Instrument tray MCLS37= Sataloff Picks/Handles/Neddles Instrument tray 3319005= Powerforma Bur Rack tray * instrument set that includes the identified tray - Amount recalled
- 3,562 trays
Where it was sold
Why it was recalled
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"
This product could cause temporary or reversible health problems — stop using it.
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