Product is a device used in adenoid surgery and is labeled as Lusk Disposable Adenoid Curettes.
FDA device recall Z-0955-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- Reason for recall
- The box label indicates that the product is a size 2 whereas a size 4 was packed inside.
- Action taken
- A Recall notification letter was mailed to each hospital account on January 29, 2004 for each type of device they received which was under recall explaining the error and asking the accounts to remove recalled product from inventory, fax them the response sheet and to return the products.
- Root cause
- Other
- Status
- Terminated
- Product code
- KBJ
- Quantity affected
- 18 boxes, 5 curettes per box
- Distribution
- Products were distributed to 23 hospitals and surgical centers in NC, NB, IN, UT, TX, NY, WI, MO, TN, ID, OK, FL, MA, WY, NJ, LA.
- Date initiated
- 2004-01-29
- Date posted
- 2004-07-20
- Date terminated
- 2012-05-03
- Location
- Jacksonville, FL
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