Product is a device used in adenoid surgery and is labeled as Lusk Disposable Adenoid Curettes.
FDA Recall Z-0955-04 · Posted 2004-07-20
Recalling FirmMedtronic Xomed, Inc.
Recall StatusTerminated
Product CodeKBJ
Date Initiated2004-01-29
Date Terminated2012-05-03
Product Quantity18 boxes, 5 curettes per box
Reason for Recall
The box label indicates that the product is a size 2 whereas a size 4 was packed inside.
Firm Action
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
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.