Recall Z-1063-2011 ยท GAA Needle, Aspiration And Injection, Disposable
Inrad, Inc
Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222, Inrad, Inc. Kentwood, MI. The device is intended for use during percutaneous biopsy and drainage procedures to obtain tissues or fluid specimens.
| Date | Feb 8, 2011 (initiated Dec 20, 2010) |
| Status | Terminated |
| Reason | This lot of product has the wrong expiration date on the carton label. The pouches contained the correct expiration date. |
| Root cause | Employee error |
| Action | The firm, Inrad Inc., sent an "URGENT FIELD CORRECTION" notice dated December 20, 2010 to its customers. The notice described the product, problem and actions to be taken by the customers. The customers were instructed to immediately examine their inventory for the affected product. If the recalled product was in stock, the customers were told to removed the affected product from the carton and dispose of carton; to disregard carton label expiration date and reference the expiration date appearing on the pouch label only, and to complete, sign and return the attached "Carton Expiration Dat |
| Quantity | 250 |
| Distribution | Nationwide Distribution: USA including states of: FL, GA, KY, NH, NJ, NM, PA , SC, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K813368 | DISPOSABLE CHIBA-TYPE NEEDLE Dlp, Inc., Jan 5, 1982 |