Recall Z-1063-2011
Inrad, Inc · initiated December 20, 2010
Product
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.
Codes / lots: 6100-7001.
Reason for recall
This lot of product has the wrong expiration date on the carton label. The pouches contained the correct expiration date.
FDA-determined cause: Employee error
Action taken
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 Date" INFORMATION FORM via fax to 616-301-779 or mail to Inrad Inc., ATTN: Director RA/QA, 4375 Donker Court SE, Kentwood, MI 49512. If you have any additional questions about this action, please call 800-558-4647 extension 102.
Details
- Recall number
- Z-1063-2011
- Initiated
- December 20, 2010
- Posted by FDA
- February 8, 2011
- Terminated
- February 9, 2011
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Quantity
- 250
- Distribution
- Nationwide Distribution: USA including states of: FL, GA, KY, NH, NJ, NM, PA , SC, WA, and WI.
- Recalling firm
- Inrad, Inc, Kentwood, MI