Recall Z-0955-04 ยท KBJ Curette, Adenoid
Medtronic Xomed, Inc.
Product is a device used in adenoid surgery and is labeled as Lusk Disposable Adenoid Curettes.
| Date | Jul 20, 2004 (initiated Jan 29, 2004) |
| Status | Terminated |
| Reason | The box label indicates that the product is a size 2 whereas a size 4 was packed inside. |
| Root cause | Other |
| 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.