Product is labeled as ''Oto-''Flex Bur'', Medtronic-Xomed brand, packed into a sterile pouch. Product is further package
FDA device recall Z-0662-03 · posted 2003-03-20 · Terminated
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- Reason for recall
- Product packaging pouches may be open thereby compomising the sterile barrier.
- Action taken
- A recall notification letter and Effectiveness Response Form were Federal Expressed Overnight Delivery to the attention of the Risk Manager at each consignee on 1/25/2003. Consignees were requested to respond and return recalled product to Medtronic Xomed in Jacksonville, FL. or they can destroy them and request credit.
- Root cause
- Other
- Status
- Terminated
- Product code
- EQJ
- Quantity affected
- 120
- Distribution
- Product was distributed to hospitals in the follwoing US states: CO, VA, MA, CA, HI, ID, VT, NY, NC, OK, MO, TX, GA, AND AL. there were no military or government accounts. There were nine internationa
- Date initiated
- 2002-01-25
- Date posted
- 2003-03-20
- Date terminated
- 2012-07-13
- Location
- Jacksonville, FL
Monitor recalls programmatically
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