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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: ALL Lots of the following models: Model 3717000 = 2 Level Instrument tray Model 3717001 = 3 Level tray (metal & radel) Model 3717006 = 2 Level Instruument tray with mat Model 3717026 = House Otology Set tray Model 3722301 = Wiet Chronic Ear Set tray Model 3747108 = Skykes Endobrow Lift tray Model 960374 = framelock tray Model *960-811 = Framelock Instrument set (includes tray 9603740 Model 960-619 = LandmarX tray Model *9731372XOM1 = Passive ENT Instrument Set (w/tray 960-619) Model MCOH0SC = Otology Plastic instrument tray Model MCO649SC = Middle Ear Instrument tray Model MCOS10SC = Instrument tray 2 level Model MCLS28 = MF Sataloff Complete Instrument tray Model MCLS37 = Sataloff Picks/Handles/Neddles Instrument tray Model 3319005 = Powerforma Bur Rack tray * instrument set that includes the identified tray
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Xomed, Inc.
- 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"
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
ALL Lots of the following models: Model 3717000 = 2 Level Instrument tray Model 3717001 = 3 Level tray (metal & radel) Model 3717006 = 2 Level Instruument tray with mat Model 3717026 = House Otology Set tray Model 3722301 = Wiet Chronic Ear Set tray Model 3747108 = Skykes Endobrow Lift tray Model 960374 = framelock tray Model *960-811 = Framelock Instrument set (includes tray 9603740 Model 960-619 = LandmarX tray Model *9731372XOM1 = Passive ENT Instrument Set (w/tray 960-619) Model MCOH0SC = Otology Plastic instrument tray Model MCO649SC = Middle Ear Instrument tray Model MCOS10SC = Instrument tray 2 level Model MCLS28 = MF Sataloff Complete Instrument tray Model MCLS37 = Sataloff Picks/Handles/Neddles Instrument tray Model 3319005 = Powerforma Bur Rack tray * instrument set that includes the identified tray
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1934-2013
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